MAUDE Adverse Event Report: COOK INC REUTER DISPOSABLE TIP DEFLECTING WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	DTDW-35-110-10
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: dqx.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 or Problem Description
The complainant reported that the reuter disposable tip deflecting wire guide was not deflecting after the first use.The physician was attempting to reposition a stent in the renal artery.It was further noted that the wire guide was stretched from the solder joint to the distal tip.There were no reported serious injuries to the patient.

• Brand Name: REUTER DISPOSABLE TIP DEFLECTING WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7910255
• Report Number: 1820334-2018-02923
• Device Sequence Number: 2305377
• Product Code: DQX
• UDI-Device Identifier: 00827002269576
• UDI-Public: (01)00827002269576(17)210603(10)6963557
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2018

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: Lay User/Patient
• Device Expiration Date: 06/03/2021
• Device Catalogue Number: DTDW-35-110-10
• Device Lot Number: 6963557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1