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	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a cougar xt 0.014" guide wire to treat a moderately tortuous, severely calcified distal lesion in the circumflex.There was no damage noted to the device packaging.There were no issues noted when removing the device from the packaging.The device was inspected with no issues.The device was prepped per ifu with no issues.The wire tip was formed by the physician.There was no resistance moving the wire forward.Excessive force was not used.The physician was working from the right radial artery and was using a medtronic ebu guide catheter.The distal wire became folded up on itself in the distal vessel.It is reported that during removal the wire broke, and a portion of the device detached and appeared trapped under the stent or in the calcium.No intervention was performed, the device portion remains trapped in the patient.No further patient injury is reported.
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: 7380612
• Report Number: 1220452-2018-00030
• Device Sequence Number: 1426616
• Product Code: DQX
• UDI-Device Identifier: 20643169453320
• UDI-Public: 20643169453320
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140695
• 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): 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2020
• Device Catalogue Number: CGRXT190HS
• Device Lot Number: G17A08362
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1