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

Model Number	G22002
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	09/30/2025
Type of Reportable Event	Malfunction
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.Our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully advanced.The basket was able to be fully advanced/retracted with some resistance and the basket was fully formed.Buckling of the proximal catheter was observed 18.4cm to 19.3cm distal to the handle.The clear tubing remains in a fixed position during advancement and retraction with the buckled portion slight compressing during retraction.Small indentations were noted at the distal end of the catheter.During our laboratory analysis, the basket was advanced through a duodenoscope.The duodenoscope has an accessory channel that is 4.2 mm in diameter.The basket was able to be advanced/retracted with slight resistance due to friction as the drive wire passes through the buckled portion.The report is considered confirmed based on the condition of the returned device as the buckled catheter aligns with the user's description of the difficulties encountered.No other anomalies were detected with the device.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 product said to be involved confirmed the report based upon the condition of the returned device.A definitive cause for this observation could not be determined because the actual use conditions could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as patient anatomy, endoscope position or progression of disease state, we could not reproduce the actual conditions of product usage during our laboratory analysis.This limits our ability to conclusively determine a cause.The instructions for use states: "after confirming desired position of basket sheath relative to target, advance basket out of sheath by pushing forward on handle." the instructions for use also indicates: "advance device through channel in short increments until basket sheath exits endoscope." basket deployment difficulties and buckling/breaking of the device can occur if the device experiences excessive pressure.Indentations at the distal end of the catheter are indicative of potential application of pressure on the catheter.Resistance in basket movement and bends in the catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.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.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 an endoscopic retrograde cholangiopancreatography, the physician selected a cook memory hard wire basket.It was reported that the user opened the package and discovered that the [basket] retraction into the sheath was difficult.With slightly additional force, the sheath kinked.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 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: 23553857
• Report Number: 1037905-2025-00776
• Device Sequence Number: 9719109
• Product Code: FFL
• UDI-Device Identifier: 00827002220027
• UDI-Public: (01)00827002220027(17)280617(10)W4948597
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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: W4948597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 55 KG