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 Problems Difficult to Fold, Unfold or Collapse (1254); Material Separation (1562)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

During an ercp to remove cbd stones, the physician used a cook memory ii double lumen extraction basket.It was reported that the on the second pass, the physician wanted to open the basket again but the basket would not come out of the sheath.He changed to another one to complete the procedure.There was no reportable information at this time.The device was received 16oct2023 and per qe initial evaluation, "during our evaluation the basket was fully retracted and would not move when the handle was manipulated.The handle was taken apart and seen that the drive wire was broken from the handle with nesting observed in the purple hub." drive wire breaks - subject of report.

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.A photo provided shows the device involved and an open pouch from the lot provided.No damage is visible in the photo and the basket is fully retracted.Our laboratory evaluation of the product said to be involved confirmed the report.The basket returned fully retracted, and no visible damage was noted.During a function test the basket would not advance when the handle was manipulated.The handle was disassembled, and it was noted the drive wire had separated from the handle with nesting inside the purple hub.For further evaluation of the drive wire cable and basket, the catheter was cut to push the basket of the sheath.The basket was fully formed and intact, and evidence of solder was present on the handle cannula at the joint.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.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 confirmed the report of unable to manipulate the basket.This report was due to a separation of the device in the handle.The cause of the separation is unknown.The instructions for use states: "confirm desired position of the basket sheath relative to the target.Advance the basket out of 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." the instructions for use also indicates: "advance the device through the channel, in short increments, until the basket sheath exits the endoscope." basket deployment difficulties and buckling/breaking of the drive wire can occur if the device experiences excessive pressure.Resistance in basket movement and bends in the catheter can occur if the elevator of the endoscope is used to deflect the device at a sharp angle.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: 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 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: 18083975
• MDR Text Key: 327522005
• Report Number: 1037905-2023-00537
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 10827002251493
• UDI-Public: (01)10827002251493(17)260522(10)W4729747
• 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: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• 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: W4729747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS TJF
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 75 KG