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

Catalog Number 025237

Device Problem Unraveled Material (1664)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol capa (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

The complainant reported that the guide wire from the bander ureteral diversion stent set unraveled when it was removed from the delivery system.The product did not make patient contact, and this product problem occurred during unpackaging/preparation.There was no reported impact to the patient.

• 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7428553
• MDR Text Key: 105941596
• Report Number: 1820334-2018-01113
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002169944
• UDI-Public: (01)00827002169944(17)191111(10)7438565
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 025237
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1