BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OEM - BALLOON BIPOLAR TEMPORARY PACING ELECTRODE KIT

    MDR report key: 9192301 · Received October 15, 2019

    Report

    Report Number
    1018233-2019-06465
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 19, 2019
    Report Date
    December 30, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    LDF
    UDI-DI
    00801741011535
    PMA / PMN Number
    K800298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS USE-RELATED. USING THE MULTI-METER T-656 AND THE TEST BOX T-657, THE RESISTANCE WAS MEASURED FOR BOTH DISTAL AND PROXIMAL END OF THE RETURNED ELECTRODE SAMPLE. THERE WAS NO INTER-CIRCUIT RESISTANCE FOR THE DISTAL END OF THE ELECTRODE, AND THE RESISTANCE AT THE PROXIMAL END OF THE ELECTRODE WAS 1.6 OHMS. THEREFORE, THE PRODUCT FAILED TO MEET SPECIFICATIONS. THE SAMPLE WAS DISSECTED AND IT WAS FOUND THAT THE DISTAL TAIL HAD BEEN DAMAGED, AS SEEN IN GFO EVALUATION PIC ATTACHED IN THE SAMPLE EVALUATION ATTACHMENTS. IT APPEARS THAT THE DISTAL LEG MAY HAVE BEEN PULLED OR STRETCH CAUSING THE DAMAGE TO THE DISTAL WIRE. THE ROOT CAUSE OF THE REPORTED EVENT IS USER ERROR IN NOT FOLLOWING THE PRECAUTIONS AND MISHANDLING THE DEVICE, RESULTING IN FAILURE TO MAINTAIN PACING FUNCTION AND REQUIRING REPLACEMENT OF DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "THIS DEVICE SHOULD BE USED ONLY BY OR UNDER THE SUPERVISION OF PHYSICIANS TRAINED IN THE TECHNIQUES OF TRANSVENOUS INTRACARDIAC STUDIES AND TEMPORARY PACING." "EXCESSIVE BENDING, TORQUEING, OR KINKING OF THE ELECTRODE CATHETER MAY CAUSE DAMAGE TO THE CATHETER INCLUDING DAMAGE TO INTERNAL WIRES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CURRENT OF THE TEMPORARY PACING ELECTRODE CATHETER WAS NOT PASSING.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CURRENT OF THE TEMPORARY PACING ELECTRODE CATHETER WAS NOT PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984012 OEM - BALLOON BIPOLAR TEMPORARY PACING ELECTRODE KIT TEMPORARY PACING ELECTRODE LDF C.R. BARD, INC. (COVINGTON) -1018233 520007P GFDP1317 00801741011535

    Patients

    Seq Age Sex Outcome Treatment
    1 80 DA