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

Catalog Number MSB-35-2X4

Device Problem Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: our evaluation of the photo provided confirmed the report.A product evaluation was performed only by the picture provided with this report because the product said to be involved was not provided to cook for evaluation.The provided picture shows the distal end of the device, and it can be seen that a portion of the drive wire has ruptured through the sheath at the distal end.A photo of the lot number was not provided.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 photo provided confirmed the report.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 web ii memory 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.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 cbd stone removal, the physician used a cook web ii memory extraction basket.It was reported that the basket sheath cracked and the basket wire was exposed as well.They physician changed to another of the same device to complete the procedure.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 white plastic bag.Provided with the returned was an open pouch from the lot number provided in the report.The label matches the product returned.The provided picture shows the distal end of the device, and it can be seen that a portion of the drive wire has ruptured through the sheath at the distal end.A photo of the lot number was not provided.Our laboratory evaluation of the product said to be involved confirmed the report.The device returned with the handle in the fully retracted position.The basket was retracted, but the tip of the basket remained protruding through the split in the distal catheter.The split measured 31mm from the distal tip.A black/brown substance was observed on the basket wires and within the clear catheter.During handle manipulation the basket advanced but met notable resistance as the distal end of the basket passed through the split in the catheter.The device was able to be fully advanced without further resistance after this point.Slight resistance was also noted during retraction when the distal end of the basket reached the split, but it was able to be fully retracted with the tip remaining protruding from the split.The basket was slightly deformed but was otherwise intact.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 and of the photo provided confirmed the report.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.To prevent damage to the device, the instructions for use (ifu) states, "this device should never be coiled in less than an 8-inch (20 cm) diameter." the instructions for use (ifu) states, "advance the basket out of the sheath by pushing forward on the handle.Caution: pulling on the sheath while advancing or retracting the basket may damage the device, rendering it inoperable." basket deployment difficulties and buckling of the drive wire can occur if the device experiences excessive pressure.Resistance in basket extension and damage to the outer catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.Prior to distribution, all web ii memory 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.

• Brand Name: WEB II MEMORY 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: 16700373
• MDR Text Key: 312866134
• Report Number: 1037905-2023-00163
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 10827002223032
• UDI-Public: (01)10827002223032(17)250712(10)W4615882
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MSB-35-2X4
• Device Lot Number: W4615882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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: OLYMPUS JF260