BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI TORQUE CONNECT GUIDEWIRE

    MDR report key: 3082574 · Received April 24, 2013

    Report

    Report Number
    3006010712-2013-00018
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    January 4, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BRIVANT, LTD.
    Product Code
    DQX
    PMA / PMN Number
    K112381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FROM THE CUSTOMER FOR EVALUATION. THE CUSTOMER HAS CONFIRMED ON THE (B)(6) 2013 THAT IT IS AVAILABLE FOR RETURN ARE FOLLOWING UP WITH THEIR THAILAND AFFILIATE TO ASK FOR THE STATUS OF THE RETURN OF THE WIRE. A FINAL REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF THE DEVICE INVOLVED IN THE INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT FEMORAL ARTERY. DURING USE OF THE CONNECT FLEX GUIDE WIRE, WHAT APPEARED TO BE FLAKED GREEN COATING WAS OBSERVED ON ANGIOGRAPHY, IN THE FOX SV PTA CATHETER, AND AFTER USE WHEN THE GUIDE WIRE WAS WIPED WITH WHITE GAUZE. A NEW GUIDE WIRE WAS USED TO COMPLETE THE CASE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR ADVERSE PATIENT EFFECTS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176218 HI TORQUE CONNECT GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. 901022-06 10111355

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other