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

Catalog Number MWB-3X6

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.The device was received at the time of this report.A follow up report will be sent.

Event Description

In preparation for a procedure, the user selected a cook memory hard wire basket.The physician opened the package and opened the basket checking the functionality and found that one of the basket wires detached.This occurred prior to patient contact; there was no impact to the patient.In addition, the user sustained no clinical consequence and there were no adverse effects to the user.

Manufacturer Narrative

Investigation evaluation: the product said to be involved was returned in a 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 basket, and a wire is broken.A photo of the lot number was not provided.Our photo and laboratory evaluation of the product said to be involved confirmed the report.The device was returned with the basket fully extended out of the catheter lumen.One of the wires on the basket had broken loose from the proximal end of the basket and was still attached at the distal end of the basket.The basket extended and retracted freely with no sign of resistance, though the wire that detached remained outside of the lumen.The basket wire was broken near the soldered joint, but there was no evidence of the wire being damaged by the buff process.No part of the device was missing.The device contained liquid and an unknown clear substance was found near the soldered joint.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.A meeting with production management and supervision was held on (b)(6) 2021 where the broken wire was examined.It was confirmed that the wire had not been damaged by the buff process, and no part of the device was missing.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: a definitive cause for this observation could not be determined because the actual prior to use testing conditions could not be duplicated in the laboratory setting.This limits our ability to conclusively determine a cause.A discrepancy or anomaly that could have contributed to the reported observation was not observed during our laboratory analysis of the returned product.Prior to distribution, all memory hard wire 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.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.

• 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: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 12960981
• MDR Text Key: 286351011
• Report Number: 1037905-2021-00669
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002220741
• UDI-Public: (01)10827002220741(17)230528(10)W4350615
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2023
• Device Catalogue Number: MWB-3X6
• Device Lot Number: W4350615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Date Manufacturer Received: 12/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2020
• 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