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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC COUGAR GUIDE WIRE; WIRE, GUIDE, CATHETER
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MEDTRONIC, INC COUGAR GUIDE WIRE; WIRE, GUIDE, CATHETER Back to Search Results
Catalog Number CGRXT190HS
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 07/28/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Fda medwatch received; mw5071669.
 
Event or Problem Description
During a cardiac catheterization intervention of the right coronary artery (rca), the distal portion of the cougar guide wire being used sheared off into the rca.A snare was used to successfully retrieve the portion of the guide wire that became lodged in the vessel.There was no harm to the patient.
 
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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 Key6910468
Report Number1220452-2017-00099
Device Sequence Number13640895
Product Code DQX
UDI-Device Identifier20643169453320
UDI-Public20643169453320
Combination Product (Y/N)N
Initial Reporter StateKY
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 Nurse
Type of Report Initial
Report Date (Section B) 09/06/2017
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 Date04/20/2020
Device Catalogue NumberCGRXT190HS
Device Lot NumberG17A02533
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/06/2017
Initial Report FDA Received Date10/03/2017
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 Required Intervention;
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