MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY HARD WIRE EXTRACTION BASKET; BILIARY CATHETER AND ACCESSORIES

Model Number	G21861
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
In preparation for an unspecified procedure, the physician selected a cook memory hard wire extraction basket.It was reported that the user opened the package and discovered the basket wire broken.This occurred prior to patient contact; there was no impact to the patient.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the picture provided with this report because the product said to be involved was not provided to cook for evaluation.The lot number provided in the photo matches this report.The labeling in the photo matches the product reported.Our evaluation of the photo provided confirmed the report.The distal end of the device is visible and the basket appears to be in a retracted position.A basket wire has broken and remains outside of the catheter.The wire has broken near the proximal end, but appears to remain securely attached at the basket's distal tip.,a product discrepancy or anomaly that could have contributed to this reported occurrence was not observed in the photo.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 evaluation of the photo provided confirmed the report of basket wire breakage.However, 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 hard wire 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.This observation occurred prior to use.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends.
Additional Manufacturer Narrative
Investigation evaluation: the product said to be involved was returned in a white plastic bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.The photo provided shows the distal end of the device and the basket appears to be in a retracted position.A basket wire has broken and remains outside of the catheter.The wire has broken near the proximal end, but appears to remain securely attached at the basket's distal tip.The labeling in the photo matches the product and lot reported.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully retracted.The basket has one broken wire detached near the proximal end of the wire and remaining attached at the distal tip of the basket.The proximal connecting cap on the handle side angle body appears to have been unscrewed.The basket advanced and retracted as intended during handle manipulation with the broken wire remaining outside of the catheter.Under magnification of the broken wire evidence was found of embrittlement of the wire material.The fracture point of the basket wire was found to be close to the basket's proximal solder point, but there was no evidence of the wire being damaged by the buff process.No parts of the device appear to be missing.No other anomalies were detected.Photos were exchanged with production leadership and manufacturing engineering on (b)(6) 2025.It was determined that the wire had been embrittled during the soldering process due to heating and reheating of the solder during the manufacturing process.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.The root cause of the broken basket wire was traced to the soldering process.Based on the visual examination it appears the basket wire was embrittled during the soldering process.This can occur during the heating and reheating of the solder and will not be visible to the operator.Production management and the department team leads were notified of this occurrence.The guidelines for soldering process has been revised to bring awareness to the risk of overheating during the soldering process and a retraining has been performed for all operators since the manufacture date of the affected lot to reduce occurrences of embrittlement.Prior to distribution, all memory hard wire 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.This observation occurred prior to use.A review of the complaint history was conducted.Quality assurance will continue to monitor for complaint trends.

• Brand Name: MEMORY HARD WIRE EXTRACTION BASKET
• Common Device Name: BILIARY CATHETER AND ACCESSORIES
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC ; 3367440157
• MDR Report Key: 22372573
• Report Number: 1037905-2025-00488
• Device Sequence Number: 19942745
• Product Code: LQR
• UDI-Device Identifier: 00827002218611
• UDI-Public: (01)00827002218611(17)280210(10)W4912458
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K851965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: G21861
• Device Catalogue Number: MWB5-1.5X3.5
• Device Lot Number: W4912458
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown