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	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: phone number: (b)(6).Investigation evaluation: the 2 devices said to be involved were returned in an open pouches from the lot number provided in the report.The labels match the device returned.Our laboratory evaluation of the 2 devices said to be involved confirmed the report.Both devices were returned with the baskets fully retracted and no external damage was noted.During our functional testing both devices allowed handle manipulation.However, neither of the baskets were responsive to handle manipulation.The device handles were disassembled, and it was found that both drive wires were separated from their respective handles with nesting in their respective purple hubs.For further evaluation of the drive wire cables and baskets, the distal catheters were cut to push the baskets out of the sheaths.Both baskets were fully formed and intact.Evidence of solder was present on both of the handle cannulas at the joint.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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 2 returned devices confirmed the report of unable to manipulate the basket.This report was due to a separation of the drive wires in the device handles.The cause of the separations 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 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: 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.
Event or Problem Description
During an endoscopic sphincterotomy, the physician used two cook memory ii double lumen extraction baskets.It was initially reported that the assist nurse manipulated the handle to unfold for capture bile duct small stones, but the handle did not work.This was interpreted to be unable to advance the basket so there was no reportable information at that time.The devices returned on 09jan2026 and during qe evaluation the handle would move on both devices however the baskets would not.Both handles were disassembled and the drive wires were disconnected from the handle with nesting in the purple hubs.[subject of report].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: 24246710
• Report Number: 1037905-2026-00059
• Device Sequence Number: 8326508
• Product Code: LQR
• UDI-Device Identifier: 00827002251496
• UDI-Public: (01)00827002251496(17)280728(10)W4958833
• 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): 02/03/2026

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: G25149
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4958833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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