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	05/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: the products said to be involved were returned in a white plastic bag.Provided with the return were four open pouches from the lot number provided in the report.The labels match the product returned.A photo was provided and reviewed.The photo shows one of the reported devices coiled, the distal end and proximal catheter are visible.The basket is fully advanced and appears to be fully formed, but the handle position is not visible in the photo.Buckling near the proximal shrink tubing is observed, evidence of the reported difficulty during retraction.Our laboratory evaluation of the products said to be involved confirmed the report.Devices #1-#4 were returned with the baskets fully advanced.Buckling of the proximal catheter near the shrink tubing was noted on all 4 devices.During functional testing, the baskets were not able to retract when attempting retraction while in a relaxed, uncoiled, position on the table top.All 4 baskets would encounter strong resistance when attempting to collapse into the catheter during retraction.Additionally, during attempted advancement when relaxed on the table top, devices #2 and #3 encountered resistance in advancement and devices #1 and #4 were unable to advance.When the catheters were fully straightened the baskets were able to advance and retract without resistance.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 4 returned devices 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.
Event or Problem Description
During an endoscopic procedure, for stone removal, the physician selected a cook memory eight wire basket.It was reported that before use, user tested the device and found out the basket could not be retracted into sheath after advanced out.This occurred with four (4) baskets.This occurred prior to patient contact; there was no impact to the patient.In addition, the user sustained no clinical consequence and there were no adverse effects to the user.

• 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: 25520681
• Report Number: 1037905-2026-00284
• Device Sequence Number: 21489624
• Product Code: LQR
• UDI-Device Identifier: 00827002215382
• UDI-Public: (01)00827002215382(17)281103(10)W4983439
• 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,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: W4983439
• 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: 05/19/2026
• Initial Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown