MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC THE WEB EXTRACTION BASKET; DISLODGER, STONE, BASKET, URETERAL, METAL

Model Number	G22776
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an endoscopic retrograde cholangiopancreatography, ercp, the physician used a cook web extraction basket.It was reported that the basket became impacted in the battery ampoule [duct/papilla].All possible maneuvers were performed to remove it but it was not possible, therefore the patient was taken to surgery.The basket was recovered by surgery (exploratory laparotomy).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 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.The ifu references potential complications as: "those associated with gastrointestinal endoscopy and ercp include, but are not limited to: pancreatitis, cholangitis, sepsis, perforation, hemorrhage, aspiration, fever, infection, hypotension, allergic reaction, respiratory depression or arrest, cardiac arrhythmia or arrest." additionally, "others associated with use of an extraction basket include, but are not limited to: impaction of object, aspiration of foreign body, localized inflammation, pressure necrosis." the ifu warns, "surgical intervention may be required if impaction occurs." prior to distribution, all web 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.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: THE WEB EXTRACTION 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: 21425474
• Report Number: 1037905-2025-00154
• Device Sequence Number: 20774480
• Product Code: FFL
• UDI-Device Identifier: 00827002227767
• UDI-Public: (01)00827002227767(17)270718(10)W4854739
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 02/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G22776
• Device Catalogue Number: WEB-2X4
• Device Lot Number: W4854739
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2024
• 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: ENDOSCOPE, UNKNOWN MAKE OR MODEL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown