MAUDE Adverse Event Report: MEDTRONIC, INC COUGAR GUIDE WIRE; WIRE, GUIDE, CATHETER

Catalog Number	CGRXT190HJ
Medical Device Problem Codes	Kinked (1339); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis summary: received for analysis was a cgrxt190hj guide wire.The guide wire was received severely stretched and with severely stretched coils.On closer visual inspection, bends, kinks and stretched coils were noted.The wire was received in one piece.The wire was severely kinked at the very proximal end of the wire.Actual measurements taken on the cougar wire were within product performance requirements at joints, along spring, coated core wire (distal section of the distal tip was not damaged), and hypo tube.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a cougar xt j-tip guide wire.It is reported that the physician stated malfunction of the guidewire during attempted lead implant.The physician also specified that it was not a lead issue.The physician noted that there was no calcifications as the device was used in the vein for crt with one of the lv leads.There is no patient injury.

• Brand Name: COUGAR GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7365147
• Report Number: 1220452-2018-00027
• Device Sequence Number: 16638411
• Product Code: DQX
• UDI-Device Identifier: 20643169452828
• UDI-Public: 20643169452828
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

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: 08/22/2019
• Device Catalogue Number: CGRXT190HJ
• Device Lot Number: G16A06202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR