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 06/19/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a clear ziploc bag with a copy of the label from the lot reported.The label matches the product returned.Our laboratory evaluation of the product said to be involved confirmed the report.The basket returned fully retracted and the handle pushed down.A clear liquid was observed within the clear tubing.During a functional test the basket would not advance when the handle was manipulated.The handle was disassembled and noted that 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.No other anomalies were detected with the devices.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 basket sheath relative to target.Advance basket out of sheath.Caution: pulling on sheath while advancing or retracting basket may damage device, rendering it inoperable.".The instructions for use also indicates: "advance device through channel, in short increments, until basket sheath exits 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.

Event Description

During an ercp, the physician used a cook memory ii double lumen extraction basket.It was initially reported that the basket would not open.This malfunction has not historically caused or contributed to a death or serious injury requiring intervention to preclude death or serious injury so it was not reportable.The device was received on 07/06/2023 and per initial qe evaluation, "during a function test the basket would not move when the handle was manipulated.The handle was disassembled and noted that the drive wire had separated from the handle with nesting inside the purple hub." this malfunction can lead to serious injury so it is a reportable event.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: 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: 17430459
• MDR Text Key: 320170999
• Report Number: 1037905-2023-00364
• Device Sequence Number: 1
• Product Code: LQR
• UDI-Device Identifier: 10827002251493
• UDI-Public: (01)10827002251493(17)260213(10)W4700888
• Combination Product (y/n): N
• 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
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• 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: W4700888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2023
• 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: SCOPE, UNKNOWN MAKE AND MODEL.