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

Catalog Number	CGRXT190HJ
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician intended to use a cougar guidewire.There was no damage noted to the device packaging.There were no issues noted when removing from the packaging per ifu.The device was inspected with no issues.The device was not prepped per ifu.The wire tip was not formed by the physician.The lesion was not pre-dilated.The lesion was in the postero-lateral trunk.Excessive force was not used during delivery.It is reported that during removal the distal end was damaged but did not come off the device.The device was removed by pulling it out of the patient.No intervention was required.No patient injury is reported.
Additional Manufacturer Narrative
Product analysis: the wire as received is coil wrapped and folded in half.There are several kinks in the wire from the return method.The wire is stretched in a distal direction from the distal bond forward to the tip.The core wire is broken at the tip and the coils are stretched.The broken end of the core wire shows necking.No components are missing.Cine image analysis: the first image shows a coronary angiography (cag) of the rca with contrast.The image captures the target lesion.No wire is present.The second image shows wires that have been delivered to the distal pda and distal rca, with the lesion at the ostium of the pda being treated with balloon inflation.Both wires appear intact.Post treatment shows good resolution of the lesion with improved flow.Wires still appear intact in the vessels.The images provided do not show the reported damage to the complaint wire.Images of the wires being withdrawn were not provided.If information is provided in the future, a supplemental report will be issued.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: 7199541
• Report Number: 1220452-2018-00007
• Device Sequence Number: 917954
• Product Code: DQX
• UDI-Device Identifier: 20643169452828
• UDI-Public: 20643169452828
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 07/29/2020
• Device Catalogue Number: CGRXT190HJ
• Device Lot Number: G17A04954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 07/24/2018; 08/08/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 08/02/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR