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	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation evaluation: one of the two devices 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.During a functional test the handle was unable to be manipulated and the basket could not be advanced.The handle was disassembled for further evaluation.It was noted that the drive wire is disconnected from the handle.There was also nesting of the wire inside the purple hub.For further evaluation of the drive wire cable and basket, the distal catheter was cut to push the basket out of the sheath.The basket was fully formed and intact.Evidence of solder was present on the handle cannula 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 one returned device said to be involved confirmed the report of unable to manipulate the basket.This report was due to a separation of the drive wire in the device handle.The cause of the separation is unknown.The second device referenced in the description of event was not provided for evaluation.Therefore, we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.It was noted in the additional questions responses that the baskets were able to be advanced and retracted prior to use.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 stone extraction in the common bile duct, the physician selected a cook memory ii double lumen extraction basket.It was initially reported that 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 mb-35-2x4-8 from the patient and use a new mb-35-2x4-8, this basket didn't move inside the cbd.So they had to use a new one of another lot number.There was no reportable information at that time.The device was received on 19may2026 and during qe investigation the basket would not move when the handle was manipulated, then the handle was disassembled.The drive wire was separated from the handle, and nesting was observed in the purple hub [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: 25513304
• Report Number: 1037905-2026-00283
• Device Sequence Number: 10553384
• Product Code: LQR
• UDI-Device Identifier: 00827002251496
• UDI-Public: (01)00827002251496(17)290102(10)W4996873
• 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): 06/15/2026

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: W4996873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown