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

Catalog Number	CGRXT190S
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use a cougar guidewire.There was no damage noted to packaging.The wire tip was formed by the physician.The device was used during a procedure in a mid saphenous vein graft, exhibiting moderate tortuosity.There were no abnormalities reported in relation to anatomy.It is noted that the device looked damaged when retrieved from the patient.It is noted that the device had stretched coils during removal.There is no injury reported.
Additional Manufacturer Narrative
Product analysis summary: the wire was received coiled up in a small bag.Visual inspection on the cougar wire detected severe damage to the coils at the distal end of the tip.A bend was noted to the wire 45cm to proximal end.During analysis under magnified view, the core wire and ribbon joint appeared intact, the analysis also revealed a break of the ribbon.Regardless of the break, the wire was received with no missing parts.The coils kept the guide wire in one piece.The coils were pulled in the analysis lab to reveal the remaining piece of the ribbon.The remaining distal broken ribbon remained attached to the tip ball, accounting for the full length of the wire with no missing parts due to the break.Actual measurements taken on the cougar wire, the measurements were within product performance requirements at joints, along spring, coated core wire, and hypo tube.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: 7013343
• Report Number: 1220452-2017-00114
• Device Sequence Number: 944077
• Product Code: DQX
• UDI-Device Identifier: 20643169452804
• UDI-Public: 20643169452804
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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: 04/27/2019
• Device Catalogue Number: CGRXT190S
• Device Lot Number: G16A03100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 11/09/2017
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 87