BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI TORQUE CONNECT GUIDEWIRE

    MDR report key: 2844745 · Received November 7, 2012

    Report

    Report Number
    3006010712-2012-00010
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 6, 2012
    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

    NO CONCLUSION CAN BE DRAWN AS TO WHAT CAUSED THE POLYMER JACKET TO PEEL AS THE GUIDEWIRE INVOLVED IN THE INCIDENT WAS NOT RETURNED AND ANALYSIS WAS NOT POSSIBLE. A BATCH HISTORY REVIEW COULD NOT BE CARRIED OUT AS THE LOT NUMBER IS UNKNOWN. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. IT WAS REPORTED THAT NONE OF THE POLYMER COATING WAS LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    AN INCIDENT REPORT WAS RECEIVED FROM ABBOTT PERSONNEL DETAILING THE FOLLOWING: "IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A LESION IN AN UNSPECIFIED ARTERY, A HT CONNECT GUIDE WIRE WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE HT CONNECT GUIDE WIRE WAS WITHDRAWN FROM THE PATIENT ANATOMY AND IT WAS NOTED THAT THE POLYMER WAS PEELING FROM THE GUIDEWIRE. REPORTEDLY, NONE OF THE POLYMER COATING REMAINED IN THE PATIENT ANATOMY. A NEW HT CONNECT GUIDE WIRE WAS USED AND ANGIOPLASTY WAS PERFORMED TO TREAT THE TARGET LESION. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI TORQUE CONNECT GUIDEWIRE GUIDEWIRE DQX BRIVANT, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1