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

Catalog Number	CGRXT190HJ
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A cougar guidewire was attempted to be used during a procedure to treat a non tortuous, non calcified lesion with chronic total occlusion in the proximal rca.No damage was noted to packaging.No issues removing the device from the packaging as per ifu.The device was not inspected.The device was not prepped as per ifu.The wire tip was not formed by the physician.The cougar was being used with a 1.5x10mm euphora balloon catheter.The guidewire was introduced into the artery.Later the balloon was introduced into the artery.There was no problem during insertion.The balloon was inflated once to nominal pressure.An image provided indicates that the euphora balloon caught on the guide wire and became severely deformed.It was reported that the damage to the euphora was due to the cougar wire.When it was time to remove the material from the patient's body, the balloon became entrapped on the wire and could n ot be removed, and the euphora became damaged.No patient injury reported.
Additional Manufacturer Narrative
Image analysis: the image shows severe twisting of the balloon catheter while the guide wire was still engaged to the catheter.The returned wire exhibited the same damage shown in the photo.Product analysis: received for analysis were a balloon catheter and a (b)(4) cougar guide wire.Both devices were engaged, the guide wire is engaged to the balloon catheter wire lumen.Severe damage to the wire and balloon catheter were noted.Bunched up coils were noted and likely due to over turning or applying torque to the guide wire during use.Distal tip ball was undamaged as received.Physical measurement.0136¿ indicated that wire outer diameter was not a contributor to the likely resistance or subsequent damage to both devices.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: 8483069
• Report Number: 1220452-2019-00039
• Device Sequence Number: 19190501
• Product Code: DQX
• UDI-Device Identifier: 00643169452824
• UDI-Public: 00643169452824
• 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
• Report Date (Section B): 07/12/2019

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: 05/28/2021
• Device Catalogue Number: CGRXT190HJ
• Device Lot Number: G18A05708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 80