MAUDE Adverse Event Report: COOK ENDOSCOPY 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 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # k171969.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The basket was returned fully retracted into the catheter.When the handle was manipulated the basket would not move.The handle was disassembled and it was noted that the drive wire had disconnected from the wire.There was nesting noted in the purple hub.For further evaluation of the drive wire cable and basket, the catheter was cut to push the drive wire cable out of the sheath.The basket was fully formed and intact, and evidence of solder was present on the handle cannula at the joint.A brown substance was observed on the distal tip of the basket.No other anomalies were detected with the device.A review of the device history record could not be conducted because the lot number was not provided.Investigation conclusion: the report of unable to open the basket was due to a separation of the device in the handle.The cause of the separation is unknown.The instructions for use indicates: "advance device through channel, in short increments, until basket sheath exits endoscope." the instructions for use also 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." 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.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 a stone removal procedure, the physician used a cook memory ii double lumen extraction basket.The physician performed removal of a stone/stones in the common bile duct via the papilla several times with the device.At another attempt of stone removal with the device after that, the handle became unable to move at all resulting in the basket unable to open.Therefore, another device was used instead to complete the procedure.This event was not reportable at the time.The device was received for evaluation on 07/07/2021.The device would not function properly when evaluated so the handle was disassembled and it was noted that the drive wire was separated from the handle with nesting inside the purple hub.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): COOK ENDOSCOPY; 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: 12240858
• MDR Text Key: 265822704
• Report Number: 1037905-2021-00347
• Device Sequence Number: 1
• Product Code: LQR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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