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

Model Number	G25149
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
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 and the handle would not move.You could feel grinding/scraping when attempting to manipulate handle.The handle was disassembled, and the drive wire was frayed however still attached.After the device was decontaminated, it was noted that the handle has now detached from the drive wire.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 unable to manipulate the basket.This report was due to a partial separation of the drive wire from the handle.During decontamination the drive wire fully separated from the handle.The cause of the drive wire damage is unknown.The instructions for use 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." the instructions for use also indicates: "advance the device through the channel, in short increments, until the basket sheath exits the endoscope." basket deployment difficulties and buckling/breaking of the drive wire can occur if the device experiences excessive pressure.Resistance in basket movement and bends in the catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.Prior to distribution, all memory ii double lumen 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.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography (ercp) for stone removal in the bile duct, the physician selected a cook memory ii double lumen extraction basket.It was initially reported that before insertion into the endoscope's forceps channel, the basket could be opened and closed.Once the device was placed along the guidewire to approach the stone in the bile duct and attempted to deploy the basket, it failed to open.There was no reportable information at that time.The device was returned on 14nov2025 and evaluated.It was observed that the device the handle would not move, and grinding could be felt in the handle when attempting to manipulate the handle.The handle was disassembled, and the drive wire was frayed but attached by a few wires that had not detached.After decontamination the device was removed, and it was noted that the handle was then disconnected from the drive wire.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.

• Brand Name: MEMORY II DOUBLE LUMEN EXTRACTION 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: 23757399
• Report Number: 1037905-2025-00818
• Device Sequence Number: 21351127
• Product Code: LQR
• UDI-Device Identifier: 00827002251496
• UDI-Public: (01)00827002251496(17)280902(10)W4967442
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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: G25149
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4967442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• 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.
• Patient Sex: Unknown