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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC COUGAR XT; WIRE, GUIDE, CATHETER
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MEDTRONIC, INC COUGAR XT; WIRE, GUIDE, CATHETER Back to Search Results
Model Number LVCXT190J
Medical Device Problem Codes Material Fragmentation (1261); Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/16/2018
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 distal end of the guidewire sheared off and was left in a branch of the coronary sinus.The implanter was unable to re-access the branch to try to retrieve the fragment.No further patient complications have been reported as a result of this event.
 
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Brand Name
COUGAR XT
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
MEDTRONIC, INC
37a cherry hill dr
danvers MA 01923
MDR Report Key7492786
Report Number1220452-2018-00046
Device Sequence Number13879271
Product Code DQX
UDI-Device Identifier20643169453290
UDI-Public20643169453290
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K032899
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/07/2018
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 Date08/09/2020
Device Model NumberLVCXT190J
Device Catalogue NumberLVCXT190J
Device Lot NumberG17A04664
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/16/2018
Initial Report FDA Received Date05/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Life Threatening;
Patient Age80 YR
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