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

Catalog Number	CGRXT190HS
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using a cougar wire when placing lv-leads in a lesion situated in the mid/ distal lm.No damage was noted to the cougar wire packaging.No issues were noted when removing the wire from the hoop.The wire was inspected and prepped per ifu.The wire tip was formed by the physician.The lesion was not pre-dilated.No previously stent was present in the lesion.No resistance was encountered during advancement and no force was applied.It was seen during radiography that the wire became damaged during placement.There was no damage to the lead.The same lead was used with a different guide wire to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Product analysis summary: the guide wire was received severely stretched and unraveled.On closer visual inspection, the core wire was found to be broken 1cm from the first distal joint.The guide wire remained connected by the coils.Proximal and distal hypo tube joints were intact.The ribbon was present and attached to the distal tip.On inspection of the proximal core wire, kinks were noted in the middle of the guide wire and the very distal end of the proximal wire.During analysis of the break, the core wire was noted to be bent at the exact location of the break.The wire outer diameter met specification.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: 6799848
• Report Number: 1220452-2017-00083
• Device Sequence Number: 1116368
• Product Code: DQX
• UDI-Device Identifier: 20643169453320
• UDI-Public: 20643169453320
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032899
• 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,Followup
• Report Date (Section B): 11/16/2017

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: 04/20/2020
• Device Catalogue Number: CGRXT190HS
• Device Lot Number: G17A02534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 10/19/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1