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

Catalog Number	CGRXT190J
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure when positioning the left ventricular lead in the in distal coronary sinus posterolateral vene, the guidewire was stuck inside the lead and did not go forward or backwards.The artery had severe tortuosity.No issues were noted with the cougar wire packaging.No issues reported when removing the wire from the packaging per ifu.The wire was inspected and prepped per ifu with no issues noted.The wire tip was formed by the physician.The lead was removed with the wire fixed inside.The wire could be removed outside of the body when force was applied.The cougar wire did not pass through a previously deployed stent.No resistance was encountered when advancing the wire.Excessive force was not applied.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis summary: the returned cougar wire was severely kinked at the proximal wire end, and also kinked in the mid-section of the core wire.The analysis revealed damage to the distal section of the wire.The wire top coils were found stretched near the distal joint of the hypo tube and start of coils.Further down, the coils section were also stretched.The distal tip ball was intact.Measurements taken on the wire outer diameter were found to be within specifications.The distal tip ball end was not damaged.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: 6799808
• Report Number: 1220452-2017-00081
• Device Sequence Number: 1723260
• Product Code: DQX
• UDI-Device Identifier: 20643169452811
• UDI-Public: 20643169452811
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K032899
• 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): 12/08/2017

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: 02/22/2020
• Device Catalogue Number: CGRXT190J
• Device Lot Number: G17A01018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 07/18/2017
• Supplement Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR