MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Catalog Number 025807

Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported during a cystectomy procedure, the wire guide that comes with the bander ureteral diversion stent was placed in the patient¿s ureter through the conduit and was clipped at one end.When the surgeon attempted to pull the wire out, the wire¿s core came out and the outer casing began to completely unravel during removal.The wire tip was separated from the core of the wire but was attached by the outer wire casing.All of the wire eventually came out but there was a lot of friction.It was reported no section of the device remained inside the patient.No additional procedures were required as a result of this issue.There were no adverse effects to the patient due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation the bander ureteral diversion stent set was not returned for an analysis and no photos were provided.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed which includes a review of the instructions for use, manufacturing instructions, and quality control data.A review of the manufacturing records for the product could not be performed as the lot number of the device was not provided.A review of complaint history for the associated device lot was unable to be performed without the lot number.The wire guide is inspected to ensure that all welds are proper, there is no damage to the coils or the mandril of the guide, and that the tfe coating is sufficient and smooth.The wire guide is shipped with a label that instructs the user to not remove the guide from a needle as damage will occur, and also warns against manipulation of the wire guide as it may also cause damage.The probable root cause of this complaint is user technique.It is advised to not remove the wire guide to avoid damage to the guide and that excessive manipulation of the guide could also cause damage.The appropriate cook personnel have been notified of this event.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.H3 other text : blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation the bander ureteral diversion stent set was not returned for an analysis and no photos were provided.Without the complaint device, a physical investigation was not able to be completed.A document based investigation has been performed which includes a review of the instructions for use, manufacturing instructions, and quality control data.A review of the manufacturing records for the product could not be performed as the lot number of the device was not provided.A review of complaint history for the associated device lot was unable to be performed without the lot number.The wire guide is inspected to ensure that all welds are proper, there is no damage to the coils or the mandril of the guide, and that the tfe coating is sufficient and smooth.The wire guide is shipped with a label that instructs the user to not remove the guide from a needle as damage will occur, and also warns against manipulation of the wire guide as it may also cause damage.The probable root cause of this complaint is user technique.It is advised to not remove the wire guide to avoid damage to the guide and that excessive manipulation of the guide could also cause damage.The appropriate cook personnel have been notified of this event.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: BANDER URETERAL DIVERSION STENT SET
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7350131
• MDR Text Key: 103273313
• Report Number: 1820334-2018-00692
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 025807
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1