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	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued.Section e: phone: (b)(6).Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.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: 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.Prior to distribution, all memory eight wire baskets are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: based on the quality engineering risk assessment no corrective action is warranted at this time.This observation occurred prior to use.A review of the complaint history was conducted.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.
Event or Problem Description
During preparation for an unspecified procedure, the physician tested two (2) cook memory eight wire basket.It was reported that the handle doesn't move.This occurred during testing; there was no patient impact.
Additional Manufacturer Narrative
Continued.Section e: phone: (b)(6).The investigation is ongoing.A follow up emdr will be submitted within 30 days of receipt of new information.
Additional Manufacturer Narrative
Continued: section e: phone: (b)(6).The investigation is ongoing.A follow up emdr will be submitted within 30 days of receipt of new information.
Additional Manufacturer Narrative
Section e: phone: (b)(6).Investigation evaluation: the 5 devices said to be involved were returned with 3 devices remaining sealed and 2 devices returned in open pouches from the lot number provided in the report.The labels match the products returned.Devices #1-3 (sealed).Our laboratory evaluation of the products said to be involved confirmed the report.Devices #1-3 were returned sealed.For further evaluation devices #1 and 2 were opened during a meeting with capa engineering and manufacturing engineering.No damage was observed on any of the devices as opened though some twisting of the catheter was observed.During our investigation we could not retract the baskets when attempting retraction while in a relaxed, uncoiled, position on the tabletop, the baskets would not retract due to encountering resistance.When the catheters were fully straightened the baskets were able to advance and retract without resistance.During efforts to retract the basket the proximal catheter of devices #1 and 2 became buckled due to the applied force.During a meeting with capa engineering device #3 was opened for further evaluation.During our investigation we could not retract the basket when attempting retraction while in a relaxed, uncoiled, position on the tabletop, the basket would not retract due to encountering resistance.When the catheter was fully straightened the basket was able to advance and retract without resistance.To assess possible interference between the drive wire and the device catheter for devices # 1-3, the device catheter assembly (including y-body, shrink tubing, and clear tubing) were replaced with materials from our stock.The devices were able to advance and retract without noted difficulty while in a relaxed position.The drive wires were noted to have evidence of an unknown substance along the length.Cleaning and adding silicone lubricant, just adding silicone lubricant, and without cleaning or added lubricant were all successful as the basket was able to advance and retract with the new catheter assembly.The inner diameter of the original catheters were measured and found to be within specifications.The root cause of the resistance or source of the unknown substance is unknown.Devices #4 & 5: our laboratory evaluation of the products said to be involved confirmed the report.Devices #4 & 5 were returned with the baskets fully advanced.During our investigation we could not retract the baskets when attempting retraction while in a relaxed, uncoiled, position on the table top, the baskets would not retract due to encountering resistance.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 products 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.

• 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: 23360925
• Report Number: 1037905-2025-00728
• Device Sequence Number: 21037290
• Product Code: LQR
• UDI-Device Identifier: 00827002215382
• UDI-Public: (01)00827002215382(17)280714(10)W4955162
• 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,Followup,Followup,Followup
• Report Date (Section B): 03/09/2026

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: W4955162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 01/15/2026; 02/11/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 01/15/2026; 02/11/2026; 03/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• 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: SCOPE, UNKNOWN MAKE AND MODEL
• Patient Sex: Unknown