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

Model Number	CGRXT190HS
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One still image was received for analysis.The image shows deformation to the distal end of the wire.It is unclear whether there is any other deformation to the mid and proximal end of the wire.Device returned coiled up in stapled inner pouch.Lot#: g19a04110 on pouch.One cougar guidewire was received for analysis.The resolute onyx device used during the procedure was not returned.Stretched coils were evident near the distal hypotube bond.Bunched up coils were seen at the first joint, and in areas near the first joint.No damage noted to the distal tip or tip ball.All joints appeared intact.No portion of the wire is broken or missing.No kink was noted on the wire.Measurements taken on the wire were met specification of 0.014¿ maximum at joints, along spring, coated core wire, and hypotube.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
One str hydro model cougar guide wire was used during a procedure to treat a lesion in a moderately tortuous distal left anterior descending (lad) artery.The lesion had 50-75% stenosis.There was no damage noted to the packaging.There was no issue noted when the device was removed from packaging.The device was inspected with no issues.The device was prepped per ifu.The wire tip was formed by the physician.The lesion was pre dilated with a 2.25 euphora balloon.The device did not pass through a previously deployed stent.Resistance was not encountered.Excessive force was not used during delivery.One 2.25 x 26 resolute onyx drug eluting stent was deployed at 14 atm for 15 sec.The resolute onyx was inspected prior to use with no issues noted.Negative prep was preformed with no issues noted.When an attempt was made to remove the stent balloon, resistance was encountered.The stent balloon was then taken back up to 3 atm and dialed back down again, but still could not be removed.The cougar wire and the onyx stent balloon were removed together.When out side of the patient body force was used to removed the wire from the stent balloon and a kink was felt in the wire.Patient is alive with no injury.
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: 9646441
• Report Number: 1220452-2020-00013
• Device Sequence Number: 14087135
• Product Code: DQX
• UDI-Device Identifier: 00643169453326
• UDI-Public: 00643169453326
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 05/01/2022
• Device Model Number: CGRXT190HS
• Device Catalogue Number: CGRXT190HS
• Device Lot Number: G19A04110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 85