BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUIDEWIRE PTFE

    MDR report key: 2193346 · Received July 26, 2011

    Report

    Report Number
    1220452-2011-00055
    Event Type
    Injury
    Date Received
    July 26, 2011
    Report Date
    July 15, 2011
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DQT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO US THAT THERE WAS A DISSECTION NOTED AFTER THE GUIDE WIRE WAS REMOVED FROM THE PATIENT AFTER A DIAGNOSTIC PROCEDURE. DURING MANIPULATION OF THE WIRE, RESISTANCE WAS FELT. THE PHYSICIAN DID NOT TAKE A FLUOROSCOPY PICTURE DURING RESISTANCE WITH THE WIRE. UPON INSPECTION OF THE WIRE POST PROCEDURE, IT WAS NOTED COIL SPLIT ON DISTAL END, AND RESULTED IN DISSECTING THE FEMORAL ARTERY. THE DISSECTION RESOLVED ON ITS OWN WITHOUT INTERVENTION. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUIDEWIRE PTFE DQT MEDTRONIC INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention