MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY HARD WIRE BASKET; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	G22002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography, ercp, to remove stones the physician used a cook memory hard wire basket.It was reported that the basket broke during the stone removal process after entering the bile duct.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.
Additional Manufacturer Narrative
Investigation evaluation: a product evaluation was performed only by the pictures provided with this report because the product said to be involved were not provided to cook for evaluation.The lot number provided in the photos matches this report.The label in the photo matches the product reported.Our evaluation of the photos provided confirmed the report.The distal end of the device is shown with the basket advanced.It can be seen on of the basket wires has broken at the proximal end but appears to remain securely attached at the basket's distal tip.No portion of the basket wire appears to be missing.Additionally, a brownish-yellow substance is observed at the distal end of the basket wires and within the distal clear catheter.In vivo photos were provided as well cataloguing the different parts of the procedure, however, as they are blurry it is difficult to interpret what is being depicted/ inconclusive for visualizing the basket wire breakage.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 photos 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 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.Based on this review, the likelihood of this type of report is rare.Quality assurance will continue to monitor for complaint trends.

• Brand Name: MEMORY HARD WIRE BASKET
• Common Device Name: DISLODGER, STONE, BASKET, URETERAL, METAL
• 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: 21662996
• Report Number: 1037905-2025-00225
• Device Sequence Number: 18229519
• Product Code: FFL
• UDI-Device Identifier: 00827002220027
• UDI-Public: (01)00827002220027(17)270325(10)W4822567
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 03/21/2025

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: G22002
• Device Catalogue Number: MWB-2X4
• Device Lot Number: W4822567
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• 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 CV-290SL.
• Patient Age: 84 YR
• Patient Sex: Female