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

Catalog Number	CGRXT190HJ
Medical Device Problem Codes	Delamination (2904); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/22/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician used a cougar wire during a primary angioplasty procedure in a mild tortuosity, non-calcified vessel.No damage was noted to packaging (shelf carton, inner packaging, hoop).No issues were noted to the device when removing it from the packaging as per ifu.The wire was inspected and prepped per ifu with no issues noted.The wire tip was not formed by the physician.The coating was moistened prior to use.It is reported that while delivering the wire to the lesion the green outer coating had given way and the wire was delaminating.The wire was stuck in the diagonal artery, and whilst trying to put it back into the lad, it was noticed that the torque was not getting transmitted.During the attempt to remove the entire system, it was noticed that wire delamination occurred either at the junction of the distal 30 mm and the harder part of the wire or a bit more proximally at the level of the proximal lad.Hence the wire was removed due to coating issues.As the wire was retracted, it is indicated that the wire continued to stretch.No device had been loaded onto the wire when this event occurred.The patient underwent emergency cabg.One piece of the wire was retrieved in the cath lab and one piece in the operation theatre.The patient is reported to be recuperating at home.
Additional Manufacturer Narrative
Procedural image review: images confirm the delivery of a wire to the diagonal artery.There is no evidence of coating coming off the wire or the unravelling of the wire in the images.A detachment appears to have occurred as there is no wire evident in the guide catheter.No images of the unravelled wire were provided.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: 7028039
• Report Number: 1220452-2017-00115
• Device Sequence Number: 1051207
• Product Code: DQX
• UDI-Device Identifier: 20643169452828
• UDI-Public: 20643169452828
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 02/12/2018

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: 03/23/2020
• Device Catalogue Number: CGRXT190HJ
• Device Lot Number: G17A01783
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2017
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 02/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Weight: 58