Device malfunctions with use of EUS-guided fine-needle biopsy devices: Analysis of the MAUDE database.

Background: The safety of endoscopic ultrasound-guided tissue acquisition through fine-needle biopsy devices is well-established in clinical trials. The real-world experience of using these devices is not known. The authors analyzed the postmarketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to answer this question. Methods: The Food and Drug Administration MAUDE database from January 2012 to June 2022 was accessed to evaluate for device malfunctions and patient-related adverse consequences of these malfunctions. Results: There were 344 device-related issues. Most issues were due to detachment or breakage of the device (n = 185 [53.7%]). Seventy-six of the breakages (40.8%) occurred during the procedure, whereas 89 cases (47.8%) occurred while removing the needle from the endoscope. The most common site of tissue biopsy at the time of needle breakage was the pancreas (44 [23.8%]).The common patient-related adverse events were retained foreign body (n = 50 [14.5%]) followed by bleeding (16, 4.6%). Six patients (3.4%) required a second intervention for removal of the retained foreign bodies including surgery in 2 cases. The device breakage damaged the endoscope in 3 cases (1.7%), and there was 1 case of needlestick injury to the nurse. Conclusion: The fine-needle biopsy devices can be associated with needle breakage and bending; these adverse events were not previously reported. Needle breakages can result in a retained foreign body that may require additional procedures including surgery. These real-world findings from the MAUDE database may inform clinical decisions and help improve clinical outcomes.

A Simplified Method of Manually Constructing Small Format Tissue Microarray for Use in Resource-Constrained Settings.

Background & Objective: Tissue microarray (TMA) is a method of harvesting small tissue cores from a number of donor paraffin tissue blocks and arraying them in a recipient paraffin block. It has numerous advantages and applications but is expensive. This study aimed to develop a simple yet efficient method of manual, small-format TMA block construction. Methods: Disposable skin punch biopsy needles were used to manually core out 4-mm cylinders from the archival donor blocks comprising tissue from 60 thyroidectomy specimens. These cores were oriented in the embedding cassette in accordance with the grid design. The molten wax was slowly dispensed and allowed to be set. Sectioning, mounting, and hematoxylin and eosin (H&E) staining were performed by a conventional method. Immunohistochemical studies, using HBME-1, CK19, and S100 antibodies, were also performed on these tissue array sections. Results: There was no core loss during processing. Technical issues like core tilt and floatation were easily tackled. Morphological identification, histological typing, and immunohistochemical analysis could be satisfactorily performed in these TMA sections. Donor blocks did not break after punching. Conclusion: This TMA construction method is simple, feasible, easily reproducible, and time-saving. It can serve as an excellent cost-effective alternative for resource-poor laboratories for carrying out immunohistochemical studies.

Deflection Analysis of Different Needle Designs for Prostate Biopsy and Focal Therapy.

OBJECTIVE: The biopsy needles currently used were designed for a transrectal biopsy and are known to experience significant deflection from the point of entry into the gland to the needle tip. METHODS: Five designs were selected for testing: 18-gauge Bard, 15-gauge lancet tip needle with 12° vet-point cannula, and trocar tip needle with 12°, 15°, and 20° vet-point cannulas. The 15-gauge needle was designed to take a variable specimen sample between 20 and 60 mm, whereas the Bard needle specimen bed was fixed at 20 mm. The needles were bench tested on a spring-loaded platform and fired into gelatin matrix with modulus of elasticity similar to human prostate. RESULTS: The Bard device with lancet tip needle deflected an average of 0.9 mm (range 0.3-1.3 mm) and 1.9° (range 0.6°-2.8°). Increasing needle diameter from 18-gauge Bard to 15-gauge variable with the same lancet tip needle design resulted in an average deflection across the 3 test lengths of 0.9 mm (range 0-2.0 mm) and 0.9° (range 0°-2.0°) with no significant difference. On the contrary, the use of the 3-point trocar tip needles with 12°, 15°, and 20° vet-point cannulas demonstrated significant reduction in the extent of deflection in both millimeters and degrees. There was no deflection at the 2- and 4-cm shots for both spring loads and preloads for the 3 vet tip angles tested. At 6 cm, the 20° vet tip performed the best. CONCLUSION: We proposed a mechanism that provides more accurate prostate sampling by combining a 3-point trocar tip on the needle with a 20° vet tip on the cutting cannula. Using the phantom, mimicking prostate gland tissue density, no deflection was revealed between 20- and 60-mm biopsy lengths, which should permit a straight sample in the majority of prostate glands and improve cancer localization for focal therapy planning.

Assessment of Factors Affecting the Usefulness and Diagnostic Yield of Core Biopsy Needles with a Side Hole in Endoscopic Ultrasound-Guided Fine-Needle Aspiration.

BACKGROUND/AIMS: A barbed puncture needle with a side hole was recently developed to improve sample quality and quantity in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). In this study, we retrospectively assessed the usefulness of this puncture needle. METHODS: Factors affecting diagnostic yield, safety, and diagnostic accuracy were investigated in 76 patients who consecutively underwent EUS-FNA for neoplastic lesions at our hospital between January and December 2013. RESULTS: The procedure was successful in all cases; the rates of sample collection and determination of the correct diagnosis were 92.1% and 89.5%, respectively. The mean number of needle passes required for diagnosis was 1.1. Complications included mild intraluminal bleeding in two patients (2.6%). Multivariate analysis revealed that lesion size (≤20 mm) was significantly associated with a decreased chance of determining the correct diagnosis. CONCLUSIONS: Core biopsy needles with a side hole are safe and provide a satisfactory diagnostic yield. However, the side hole may potentially reduce the rate of making the correct diagnosis in small lesions.

Assessment of Factors Affecting the Usefulness and Diagnostic Yield of Core Biopsy Needles with a Side Hole in Endoscopic Ultrasound-Guided Fine-Needle Aspiration

BACKGROUND/AIMS: A barbed puncture needle with a side hole was recently developed to improve sample quality and quantity in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). In this study, we retrospectively assessed the usefulness of this puncture needle. METHODS: Factors affecting diagnostic yield, safety, and diagnostic accuracy were investigated in 76 patients who consecutively underwent EUS-FNA for neoplastic lesions at our hospital between January and December 2013. RESULTS: The procedure was successful in all cases; the rates of sample collection and determination of the correct diagnosis were 92.1% and 89.5%, respectively. The mean number of needle passes required for diagnosis was 1.1. Complications included mild intraluminal bleeding in two patients (2.6%). Multivariate analysis revealed that lesion size (< or =20 mm) was significantly associated with a decreased chance of determining the correct diagnosis. CONCLUSIONS: Core biopsy needles with a side hole are safe and provide a satisfactory diagnostic yield. However, the side hole may potentially reduce the rate of making the correct diagnosis in small lesions.