MAUDE Adverse Event Report: COOK INC AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number	THSF-35-260-AES-SGH-BH
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2015
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 physician was using the amplatz extra-stiff support heparin coated wire guide for an endovascular aneurysm repair (evar) with approach from the right common femoral artery (cfa).However, when the wire was being inserted into the sheath, it was found to have a kink with the inner wire protruding approximately 4cm from the tip.The procedure was continued with another wire, and there were no injuries or additional procedures reported.

• Brand Name: AMPLATZ EXTRA-STIFF SUPPORT HEPARIN COATED WIRE GUIDE
• Common Device Name: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7896245
• Report Number: 1820334-2018-02939
• Device Sequence Number: 148470
• Product Code: DQX
• UDI-Device Identifier: 00827002116740
• UDI-Public: (01)00827002116740(17)200511(10)5799455
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

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: 05/11/2020
• Device Catalogue Number: THSF-35-260-AES-SGH-BH
• Device Lot Number: 5799455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1