MAUDE Adverse Event Report: COOK INC ENDO-SOF MULTI-LENGTH URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number MLSCS-060022-32-AQ-JPRPC

Device Problems Break (1069); Device Damaged Prior to Use (2284); Structural Problem (2506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (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 tip of the wire guide from the endo-sof multi-length ureteral stent set broke (separated) when the user pulled it from the holder.Another product was used instead.It was further noted that polymer material was missing from the distal tip of the wire guide which resulted in exposure of the inner mandril wire.This occurred prior to any patient contact, and there was no reported patient impact.

• Brand Name: ENDO-SOF MULTI-LENGTH URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 8110095
• MDR Text Key: 128741276
• Report Number: 1820334-2018-03463
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002542747
• UDI-Public: (01)00827002542747(17)161201(10)U2437277
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Catalogue Number: MLSCS-060022-32-AQ-JPRPC
• Device Lot Number: U2437277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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