MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC FUSION WIRE GUIDED EXTRACTION BASKET; LQR DISLODGER, STONE, BILIARY

Catalog Number	FS-XB-2X4
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.Based on the report a device failure was not identified, the non-lithotripsy basket became impacted on a stone which required the use of forceps to remove the basket wires from the stone to facilitate device removal.The instructions for use (ifu) includes the following to caution the user: "if withdrawal of the basket from the biliary duct is restricted, surgical intervention may be necessary." the ifu also includes the following warning "device is not lithotripsy compatible.Use of this device with a mechanical lithotriptor may result in device failure and/or basket impaction.Surgical intervention may be required if impaction occurs." the instructions for use also includes the following potential complications: "other potential complications associated with biliary stone or foreign body removal include but are not limited to: impaction of the object, aspiration of the foreign body, localized inflammation, pressure necrosis, perforation and ductal trauma." prior to distribution, all fusion wire guided 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: a review of the complaint history was conducted and this represents an isolated occurrence.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During stone removal from the common bile duct, the physician used a cook fusion wire guided extraction basket.It was reported that the basket would not retract fully inside the duct.The tip of the basket broke off.The device was removed and a forcep was used to remove the broken portion of the basket.Based on information received from the rep on 09/26/2023 stating that the basket tip would not break so it would not retract, we are interpreting this to mean that the basket became impacted with the stone and they used the forceps to pull the wires off the stone to allow basket removal from the patient.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: FUSION WIRE GUIDED EXTRACTION BASKET
• Common Device Name: LQR DISLODGER, STONE, BILIARY
• Manufacturer (Section D): WILSON-COOK MEDICAL INC; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 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: 17842110
• Report Number: 1037905-2023-00469
• Device Sequence Number: 17937664
• Product Code: LQR
• UDI-Device Identifier: 00827002319059
• UDI-Public: (01)00827002319059(17)251121(10)W4658331
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K171969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2023

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 Expiration Date: 11/21/2025
• Device Catalogue Number: FS-XB-2X4
• Device Lot Number: W4658331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2022
• 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: PENTAX SCOPE, UNKNOWN MODEL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown