MAUDE Adverse Event Report: COOK INC STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Model Number	G00362
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2015
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
It was reported that the flexible tipped wires had a tendency to bend or fray while being inserted into the patient.There were no injuries or additional procedures reported.Additional information had been requested but not provided.

• Brand Name: STRAIGHT AND CURVED DOUBLE FLEXIBLE TIPPED WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7891426
• Report Number: 1820334-2018-02971
• Device Sequence Number: 13495200
• Product Code: DQX
• UDI-Device Identifier: 00827002003620
• UDI-Public: (01)00827002003620(17)190301(10)4784042
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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: 03/01/2019
• Device Model Number: G00362
• Device Catalogue Number: TDOC-35-145-0-3
• Device Lot Number: 4784042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/19/2018
• Patient Sequence Number: 1