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

Catalog Number	CGRXT190HJ
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2017
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 used a cougar guide wire when treating a lesion in the mid lad; lesion was non-tortuous and moderately calcified.The lesion was pre-dilated.There was no damage noted to packaging.No issues were noted to the device when removing from the packaging per ifu.The guidewire was prepped per ifu with no issues noted.The guidewire passed through a previously deployed stent.Resistance was encountered when advancing the guidewire, excessive force was not applied.During the procedure the guidewire was advanced through a previously deployed medtronic stent however the tip of the guidewire got caught in a stent strut.The previously deployed stent was not displaced, the guidewire got stuck between the strut of the stent previously implanted and the vessel.It is indicated that the guide wire tip did not break off, it got stuck and the fibres became loose.The wire was successfully removed from the patient.Patient is alive with no injury.
Additional Manufacturer Narrative
Product analysis summary: the analysis revealed severe damage to the cougar wire assembly.The ribbon and flat wire joint was received pulled apart and the coil wire unraveled to the point of break.First joint and the distal tip section as received exhibited no damage in the direction of the tip ball.The whole length of the wire was accounted for, with no missing part of the cougar wire.During outer diameter measurements, the wire was measured and found in accordance with performance specification at joints, along the spring, coated core wire, and the hypotube.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: 6799836
• Report Number: 1220452-2017-00082
• Device Sequence Number: 16276470
• Product Code: DQX
• UDI-Device Identifier: 20643169452828
• UDI-Public: 20643169452828
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/01/2017

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: 11/23/2019
• Device Catalogue Number: CGRXT190HJ
• Device Lot Number: G16A08448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1