MAUDE Adverse Event Report: COOK INC BENTSON STRAIGHT FIXED CORE WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	TSFB-35-145
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This mdr is being filed after the associated complaint was reviewed under remediation protocol cap (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported that the bentson straight fixed core wire guide would not advance in the sheath.The wire coating was reportedly stripped from the wire guide, so another device was used to complete the lower extremity arteriogram.It was further noted that there was coil elongation near the distal end of the device, and separation of the distal weld connection from the safety wire and coil.This product issue occurred prior to patient contact, and it did not result in any reported impact on the procedure.

• Brand Name: BENTSON STRAIGHT FIXED CORE WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7897916
• Report Number: 1820334-2018-02893
• Device Sequence Number: 1473226
• Product Code: DQX
• UDI-Device Identifier: 00827002006911
• UDI-Public: (01)00827002006911(17)200504(10)5783066
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2020
• Device Catalogue Number: TSFB-35-145
• Device Lot Number: 5783066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1