MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC WEB II MEMORY EXTRACTION BASKET; BILIARY CATHETER AND ACCESSORIES

Model Number	G22303
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography, ercp, the physician used a cook web ii memory extraction basket.It was reported that during an attempt to extract stones, the basket was maneuvering around the stone and attempting to crush it when the drive wire detached from the handle and exited the plastic sheath.The device was removed, the procedure was halted, and it could not be completed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in an open pouch from the lot number provided in the report.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully retracted into the tubing.The drive wire has ruptured through the proximal tubing.The clear catheter has torn from 30cm distal to the purple shrink tube to the purple shrink tubing, including an additional 10mm torn into the purple shrink tubing.During a function test the handle would move freely however the drive wire segment ruptured through the tubing would buckle and the basket would not advance.The basket was pulled by the tip out of the distal end of the catheter for inspection, the basket was found to be significantly deformed, likely due to force during attempted fracture of the stone, but otherwise intact.A yellow substance was noted within the basket wires.Basket retraction was possible, but with some noted resistance.No other anomalies were detected with the device.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: our evaluation of the product said to be involved confirmed the report.The proximal drive wire has ruptured through the sheath.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.To prevent damage to the device, the instructions for use (ifu) states, "this device should never be coiled in less than an 8-inch (20 cm) diameter." the instructions for use (ifu) states, "confirm the desired position of the basket sheath relative to the target.Advance the basket out of the sheath by pushing forward on the handle.Caution: pulling on the sheath while advancing or retracting the basket may damage the device, rendering it inoperable." basket deployment difficulties and buckling of the drive wire can occur if the device experiences excessive pressure.Resistance in basket extension and damage to the outer catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.Prior to distribution, all web ii memory extraction baskets are subjected to a visual inspection and functional testing to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• Brand Name: WEB II MEMORY EXTRACTION BASKET
• Common Device Name: BILIARY CATHETER AND ACCESSORIES
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC ; 3367440157
• MDR Report Key: 22903154
• Report Number: 1037905-2025-00618
• Device Sequence Number: 8931859
• Product Code: LQR
• UDI-Device Identifier: 00827002223035
• UDI-Public: (01)00827002223035(17)270916(10)W4870608
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: K171969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G22303
• Device Catalogue Number: MSB-35-2X4
• Device Lot Number: W4870608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS 190 SCOPE
• Patient Sex: Unknown