MAUDE Adverse Event Report: WILSON-COOK MEDICAL INC MEMORY II DOUBLE LUMEN EXTRACTION BASKET; LQR DISLODGER, STONE, BILIARY

Catalog Number MB-35-2X4-8

Device Problem Off-Label Use (1494)

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

Event Date 03/09/2023

Event Type  malfunction  

Event Description

During a metal stent revision, the physician used a cook memory ii double lumen extraction basket to remove sludge.It was reported that the physician inserted the basket into the metal stent in the duct, opened the basket and swept it down.They noted a broken wire in the basket in the endoscopic images.The memory basket was removed from the scope, the inside of the metal stent was cleaned using a new memory basket, and a plastic stent was additionally inserted.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 an open pouch from the lot number provided in the report.The label matches the product returned.Our evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully retracted into the catheter lumen except for the separated wire which remained outside of the catheter.The separated wire had broken at the proximal end of the basket but was still attached at the distal end of the basket.The basket extended and retracted without resistance with the broken wire remaining outside of the catheter.The fracture point of the basket wire was found to be close to the basket's proximal solder point.There was no evidence of the basket being damaged during the buffing process.No parts of the device appear to be missing.Clear liquid was present in the catheter.A brown substance was present on the basket wires and fibers were present inside of the basket.No other anomalies were detected.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 of basket wire breakage.The description of event states that the device was used to removed sludge from within a metal stent.This is outside the intended use for this device.The instructions for use states: "this device is used for the endoscopic removal of stones in the biliary system and foreign bodies." use of this device within a metal stent is a likely cause for wire breakage.Prior to distribution, all memory ii double lumen 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.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.Additional comments regarding this report: based on the information provided that the memory ii double lumen extraction basket was used to remove sludge from a metal stent, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

• Brand Name: MEMORY II DOUBLE LUMEN EXTRACTION 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: 16689079
• MDR Text Key: 312883364
• Report Number: 1037905-2023-00160
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 10827002251493
• UDI-Public: (01)10827002251493(17)260113(10)W4692035
• Combination Product (y/n): N
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4692035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2023
• 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: DUODENOSCOPE - OLYMPUS TJF-260V