MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY II DOUBLE LUMEN EXTRACTION BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number MB-35-2X4-8

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: visi 2 guidewire, 0.025 straight.Investigation evaluation: our laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully retracted and a clear liquid inside of the tubing.During a functional test the basket would not move when the handle was manipulated.The handle was taken apart and it was noted that the drive wire had separated from the handle with nesting inside of 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.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: 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.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 endoscopic procedure, the physician used a memory ii double lumen extraction basket (mb-35-2x4-8).The doctor wanted to remove the stone in the common bile duct (cbd) by using the mb-35-2x4-8.Prior to insertion, the nurse checked the basket and it was not a problem.The mb-35-2x4-8 was inserted into the cbd, however the basket did not come out from the sheath.The handle of basket did not move so they removed the basket, opened a new mb-35-2x4-8's packaging, and confirmed that the basket was working fine.There was not a problem with the new basket.However, after entering the patient's duct, the handle of the second basket also did not move.The basket did not come out so they removed the second mb-35-2x4-8 and the new (third) mb-35-2x4-8 was used.The device was received on 14 july 2020, and it was determined that the drive wire separated from the handle.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: FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL
• 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: scottie fariole ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 10376211
• MDR Text Key: 241380175
• Report Number: 1037905-2020-00310
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002251493
• UDI-Public: (01)10827002251493(17)230309(10)W4328259
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2020

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 Expiration Date: 03/09/2023
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4328259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2020
• 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