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

Model Number	LVCXT190J
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2018
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
It was reported that during the implant procedure the guidewire broke and a portion remained in the coronary sinus.When the guidewire piece was removed, it was noted the distal end was missing.An interventionist was called to the procedure and the remaining guidewire piece was snared from the heart.The implant procedure was then completed as planned.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the guidewire was returned and analyzed the analysis indicated that the guidewire was kinked/buckled.Visual analysis of the lead indicated damage during use.If information is provided in the future, a supplemental report will be issued.

• Brand Name: COUGAR XT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7923662
• Report Number: 1220452-2018-00113
• Device Sequence Number: 16596103
• Product Code: DQX
• UDI-Device Identifier: 00643169453296
• UDI-Public: 00643169453296
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K032899
• 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): 03/12/2019

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: 06/04/2021
• Device Model Number: LVCXT190J
• Device Catalogue Number: LVCXT190J
• Device Lot Number: G18A05870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 03/12/2019
• 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: 81 YR