BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI TORQUE CONNECT GUIDEWIRE

    MDR report key: 2960513 · Received January 25, 2013

    Report

    Report Number
    3006010712-2013-00003
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 25, 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

    DIMENSIONAL VERIFICATION WAS CARRIED OUT ON THE RETURNED DEVICE AND IT WAS FOUND TO BE WITHIN SPECIFICATION. THE INTEGRITY OF THE PTFE COATING PROXIMAL TO THE DAMAGED SECTION REMAINED INTACT. A SECTION OF THE PROXIMAL END OF THE COATING THAT REMAINED INTACT HAS BEEN SUBMITTED TO OUR INTERNAL DESIGN ASSURANCE LABORATORY FOR A PTFE COATING ADHERENCE TEST. UPON REVIEW OF THESE RESULTS FOR A FINAL REPORT WILL BE SUBMITTED. THE LOT HISTORY RECORD WAS REVIEWED FOR CHARACTERISTICS RELATING TO PTFE COATING. THE REVIEW DEMONSTRATED THE LOT WAS MANUFACTURED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) BELOW-THE-KNEE WITH THE CONNECT GUIDE WIRE IN THE TIBIAL ARTERY. IT WAS OBSERVED THAT THE TEFLON COATING WAS COMING OFF THE GUIDE WIRE DURING THE PROCEDURE. IT WAS ALSO REPORTED THAT TOO MUCH STRENGTH MAY HAVE BEEN APPLIED TO THE GUIDE WIRE DURING THE ATTEMPT TO CROSS THE CTO LESION. THE GUIDE WIRE WAS RETRACTED FROM THE PATIENT AND REPLACED WITH ANOTHER GUIDE WIRE TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE NEW GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO MEDICAL INTERVENTION PERFORMED ON THE PATIENT AS A RESULT OF THE TEFLON COATING PEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35430 HI TORQUE CONNECT GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. 901022-02 90021509

    Patients

    Seq Age Sex Outcome Treatment
    1