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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. NITREX NITINOL GUIDEWIRE; WIRE, GUIDE, CATHETER
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MEDTRONIC, INC. NITREX NITINOL GUIDEWIRE; WIRE, GUIDE, CATHETER Back to Search Results
Model Number N143001
Medical Device Problem Codes Entrapment of Device (1212); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/25/2020
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
A nitrex guide wire was being used and it was reported that piece of the guide wire broke off the distal tip and was retained within the arterial vessel during angio procedure of the lower extremity.Physician determined that there was no way to remove the fragment and it was safe to leave within the vessel.Patient was discharged home next day and will be followed up for normal post surgical monitoring.No further patient injury reported.
 
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Brand Name
NITREX NITINOL GUIDEWIRE
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key9942465
Report Number2182208-2020-00692
Device Sequence Number14162056
Product Code DQX
UDI-Device Identifier00821684058121
UDI-Public00821684058121
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K040345
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) 04/09/2020
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 Date08/01/2022
Device Model NumberN143001
Device Catalogue NumberN143001
Device Lot Number11174382
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/03/2020
Initial Report FDA Received Date04/09/2020
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 Hospitalization;
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