MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY EIGHT WIRE BASKET; BILIARY CATHETER AND ACCESSORIES

Model Number	G21538
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic procedure, the physician selected a cook memory eight wire basket.It was reported that the user checked the device before use and found out the basket could not be retracted.User changed to a new one to complete the procedure.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 a white plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.A photo of the device labeling was provided and reviewed.The lot number matches this report.The label matches the product reported.Our laboratory evaluation of the product said to be involved confirmed the report.The device returned with the basket fully advanced.Buckling was observed in the clear catheter distal to the white shrink tubing.While the device was relaxed on the table top, the basket was not able to retract.The basket would retract to the point before it would begin to fold into the catheter and then reach resistance which exacerbated the catheter buckling and prevented retraction.When the device was fully straightened retraction became possible with some friction as the drive wire passed through the buckled portion of the catheter.When advanced in the relaxed position the basket encounters slight resistance, but is able to advance.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 laboratory evaluation of the returned device confirmed the report of difficulty advancing and/or retracting.A corrective action (capa) has been initiated to address instances of difficulty during basket advancement and retraction.The product said to be involved is included in the scope of the corrective actions.Prior to distribution, all memory eight wire 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: a corrective action (capa) has been initiated in an effort to reduce occurrences of this nature.The product said to be involved is included in the scope of the corrective action.This observation occurred prior to use.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends.

• Brand Name: MEMORY EIGHT WIRE BASKET
• Common Device Name: BILIARY CATHETER AND ACCESSORIES
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC 27105
• Manufacturer (Section G): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston salem NC 27105
• Manufacturer Contact: sabrina o¿brien ; 4900 bethania station rd; winston salem, NC 27105 ; 3367440157
• MDR Report Key: 25526306
• Report Number: 1037905-2026-00287
• Device Sequence Number: 5547443
• Product Code: LQR
• UDI-Device Identifier: 00827002215382
• UDI-Public: (01)00827002215382(17)280710(10)W4954511
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K171969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: G21538
• Device Catalogue Number: MB5-2X4-8
• Device Lot Number: W4954511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown