MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY EIGHT WIRE BASKET; LQR DISLODGER, STONE, BILIARY

Catalog Number MB5-2X4-8

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  malfunction  

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.Prior to distribution, all memory eight 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: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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 Description

During an ercp, endoscopic retrograde cholangiopancreatography, the physician used a cook memory eight wire basket.It was reported that when the user grasped the bile duct stone and was pulling it out of the bile duct, he noticed in the endoscopic image that a basket wire was sticking out.The procedure was completed using another memory eight wire basket.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.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a clear 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 had a broken wire detached at the proximal end of the wire and remaining attached at the distal tip of the basket.A dark substance was observed on the basket wires and within the clear catheter.The basket was able to fully advance and retract during handle manipulation.The broken wire would remain outside of the catheter during retraction.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.A lab meeting was held with production and manufacturing engineering on 18mar2024.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.Prior to distribution, all memory eight wire baskets are subjected to a visual inspection and functional testing to ensure device integrity.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.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.

• Brand Name: MEMORY EIGHT WIRE BASKET
• Type of Device: 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: 18857404
• MDR Text Key: 337293200
• Report Number: 1037905-2024-00135
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 10827002215389
• UDI-Public: (01)10827002215389(17)261227(10)W4796321
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171969
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MB5-2X4-8
• Device Lot Number: W4796321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCOPE, UNKNOWN MAKE AND MODEL.