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 Problem Off-Label Use (1494)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation evaluation: the photo provided shows the drive wires protruding from the sheaths.Our laboratory evaluation of the products said to be involved confirmed the report.Both devices were returned with the baskets retracted into the sheath.Both devices had the drive wire ruptured through the sheath at the base of the handle.During a functional test the baskets would not move when the handle was manipulated.The sheath in device #1 was split approximately 15.6 cm to 20.3 cm from the proximal end.The sheath in device #2 was split from 15.9 cm to 20.1 cm from the proximal end.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 user indicated that the extraction basket was used to remove pancreatic stones.The memory ii double lumen extraction basket is not intended to be used for removal of pancreatic stones.The intended use for this device states, "this device is used for the endoscopic removal of biliary stones and foreign bodies." use of the device against its intended use is the most likely cause for the reported observation.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 possible device history records 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.Additional comments regarding this report: based on the information provided that the device was used for removal of pancreatic stones, a cook representative has been directed to contact the medical facility involved in an effort to promote further education and understanding related to appropriate usage of this product.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp) procedure, the physician used two cook memory ii double lumen extraction baskets.The device was used for ercp with the approach from the duodenal papilla and endoscopic removal of pancreatic stones.After crushing pancreatic stones with extracorporeal shock wave lithotripsy (eswl), the physician attempted to collect the stones with the basket.However, small stones got stuck around the basket tip.In order to collect the basket, he removed it from the endoscope though he felt resistance.After cleaning the basket, he advanced the basket to the target site for the second collecting stones and attempted to open the basket, but he found that it could not be opened.Then, he used another memory ii double lumen extraction basket, but the same issue as the first one experienced happened to it, and it could not be opened either.Therefore, another product was used instead.Additional information was provided on 26-feb-2020 and 03-mar-2020 indicating the devices were used for ercp with the approach from the duodenal papilla and endoscopic removal of pancreatic stones.After crushing pancreatic stones with extracorporeal shock wave lithotripsy (eswl), the physician attempted to collect the stones with the baskets.However, small stones got stuck around the basket tip.In order to collect the baskets, the physician removed it from the endoscope though he felt resistance.After cleaning the baskets, he advanced the basket to the target site for the second collecting stones and attempted to open the basket, but he found that it could not be opened.He removed the device from the patient's body again and checked it, confirming that the proximal part (near the handle) of the catheter got damaged.However, it is unknown if he used the second device for the second attempt like when the first device was used.In other words, the things for sure are the issue that the basket could not be opened happened to the first device, and the issue that the proximal part (near the handle) of the catheter got damaged occurred to both the first and the second device [subject of this report].The damage at the proximal part (near the handle) of the catheter is protrusion of the inner wire.Another cook memory basket was used 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.

• 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: 9853311
• MDR Text Key: 227200421
• Report Number: 1037905-2020-00148
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002251493
• UDI-Public: (01)10827002251493(17)221118(10)W4287648
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Catalogue Number: MB-35-2X4-8
• Device Lot Number: W4287648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2019
• 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