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

Catalog Number	CGRXT300HS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the wire was engaged to a balloon catheter.Od measurements taken for the wire were found within spec.Due to the condition of the returned device functional testing was not possible.The wire was visually inspected as it was received engaged to the balloon catheter.The wire exhibited stretched and bunched up coils right after the tip of the balloon catheter.
Event or Problem Description
Physician intended to use a cougar guidewire.Device was inspected before use.Device was prepped before use no issues noted.The wire tip was formed by the physician.Femoral approach was used.It is reported that resistance was experienced during insertion.It is unknown if the resistance was with another device or during initial insertion.Physician did not continue to use the cougar wire.No patient injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 6642855
• Report Number: 1220452-2017-00057
• Device Sequence Number: 1082385
• Product Code: DQX
• UDI-Device Identifier: 20643169452781
• UDI-Public: 20643169452781
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K032899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2017

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: 11/18/2018
• Device Catalogue Number: CGRXT300HS
• Device Lot Number: G15A10354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 06/20/2017; 06/20/2017
• Initial Report FDA Received Date: 06/15/2017
• Supplement Report FDA Received Date: 07/14/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1