BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI TORQUE CONNECT GUIDEWIRE

    MDR report key: 3063546 · Received April 12, 2013

    Report

    Report Number
    3006010712-2013-00017
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 11, 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

    A BATCH HISTORY REVIEW WAS CARRIED OUT WHICH DEMONSTRATED THAT THE GUIDEWIRE WAS MANUFACTURED TO SPECIFICATION. I WILL FORWARD THE FINAL REPORT ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN INSERTING A 018 HI-TORQUE (HT) CONNECT GUIDE WIRE INTO AN UNSPECIFIED GUIDING CATHETER, VIA COMMON FEMORAL ARTERY ACCESS, SOME GREEN POWDER (RESIDUE) OF THE HYDROPHOBIC COATING ON THE PROXIMAL PART OF THE GUIDE WIRE WAS OBSERVED AT THE NEEDLE GUIDE. THE HT CONNECT GUIDE WIRE WAS WITHDRAWN FROM THE GUIDING CATHETER AND THE PROCEDURE WAS COMPLETED VIA USE OF A NON-ABBOTT GUIDE WIRE AND SUCCESSFUL DEPLOYMENT OF AN UNSPECIFIED STENT IN THE RIGHT COMMON ILIAC ARTERY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. ADDITIONAL INFORMATION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157838 HI TORQUE CONNECT GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. 901022-03 10122343

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other