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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 N180801
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Unspecified Tissue Injury (4559)
Date of Event 04/17/2021
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 ir physician was using a nitrex 80cm guidewire for a nephrostomy case.During procedure, physician went to pull the wire out and it sheared off inside the patient.The physician used a snare and retrieved the fractured wire.No further 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 Key11722635
Report Number2182208-2021-01661
Device Sequence Number3018338
Product Code DQX
UDI-Device Identifier00763000185398
UDI-Public00763000185398
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K040345
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/26/2021
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 Date10/01/2023
Device Model NumberN180801
Device Catalogue NumberN180801
Device Lot Number5995232
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/20/2021
Initial Report FDA Received Date04/26/2021
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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