MAUDE Adverse Event Report: COOK ENDOSCOPY MEMORY HARD WIRE BASKET; FFL, DISLODGER, STONE, BASKET, URETHRAL, METAL

Catalog Number MWB-2X4

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter; occupation: unknown.Investigation evaluation: the product said to be involved was returned in bio bag.Provided with the return was an open pouch from the lot number provided in the report.The label matches the product returned.Photos from the customer show the device and its packaging, and the lot number seen in the photo matches the returned product label.Our photo and laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket wires fully extended out of the catheter lumen.The tip of the basket has detached and did not return.The basket wires are no longer attached at the distal end, but remain attached at the proximal end.There was evidence of solder present on the basket wires at the distal end, and there was fluid in the catheter lumen.Without the distal tip included in the return, it could not be confirmed if the wires detached due to breakage or due to a failure of the solder joint.A product discrepancy or anomaly that could have contributed to this reported occurrence was not observed.A meeting with production management and supervision was held on 12/11/2020 and the tip of the basket wires were examined.It could not be confirmed that the tip had been damaged during production.It is unknown how the distal end detached.The device history record for the lot number said to be involved was reviewed.The device history record contains nonconformances that could potentially be related to the basket tip detaching.The device goes through various inspections prior to leaving the facility.These inspections would have removed any nonconforming devices prior to distribution.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.Retraining was completed for the operator out of an abundance of caution although we could not confirm a defect in the manufacturing process to attach the device tip.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: a review of the complaint history was conducted and this represents an isolated occurrence.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.

Event Description

During an endoscopic retrograde cholangiopancreatography (ercp), the physician used a memory hard wire basket.The physician captured the stone with the device, then pulled the handle to close the basket and stated that it was very tight to pull the handle.The physician pulled the handle with additional force and discovered that the basket was broken under x-ray image.The physician retracted the device immediately and changed to another of the same device to complete the procedure.Our evaluation of the returned device determined that the basket tip is missing and was not included in the return of the device.This information was communicated to the user facility and the location of the missing section is unknown.The initial reporter stated that a section of the device did not remain inside the patient¿s body; however the location of the missing section detected during our laboratory evaluation is unknown.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 HARD WIRE 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: 11020843
• MDR Text Key: 251107006
• Report Number: 1037905-2020-00558
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002220024
• UDI-Public: (01)10827002220024(17)230323(10)W4333791
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Catalogue Number: MWB-2X4
• Device Lot Number: W4333791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR