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	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography to remove stones from the common bile duct, the physician used a cook memory eight wire basket.It was initially reported the nurse opened the packaging of the new product and inspected the basket for any abnormalities before inserting it into the scope, and found none.However, when they positioned the basket inside the bile duct and manipulated the handle, it did not move.The basket also did not come out of the sheath.Therefore, they had to remove the mb5-2x4-8 from the patient and use a new mb5-2x4-8.There was no reportable information at that time.The device was received on 06feb2026 and the basket was fully advanced, and the basket would not retract.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 advanced.Buckling of the sheath was observed at the proximal end and there was a bend in the handle cannula.During our investigation we could not retract the basket and noted the kinking at the base of the handle tubing was kinking at 17cm to 17.4cm distal to the handle.When attempting retraction while in a relaxed, uncoiled, position on the table top, the basket would not retract due to encountering resistance and the buckled portion of the catheter compressed further.When the catheter was fully straightened the basket is able to advance and retract with minimal resistance.Some friction was felt as the drive wire passed through the buckled portion of the sheath.A yellow substance was noted on the white shrink tubing and a brown substance was observed within the distal catheter.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 product said to be involved confirmed the report of difficulty advancing and/or retracting.The cause of the advancement and retraction difficulty is unknown.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.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: 24483575
• Report Number: 1037905-2026-00103
• Device Sequence Number: 10638809
• Product Code: LQR
• UDI-Device Identifier: 00827002215382
• UDI-Public: (01)00827002215382(17)280808(10)W4962244
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K171969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: W4962244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• 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 TJF-260V SCOPE; VISIGLEDE2 STRAIGHT 0.025"
• Patient Sex: Unknown