BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 100018 · Received June 24, 1997

    Report

    Report Number
    MW1011545
    Event Type
    Malfunction
    Date Received
    June 24, 1997
    Date of Event
    June 5, 1997
    Report Date
    June 16, 1997
    Manufacturer
    HEART TECHNOLOGY, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ROTO FLOPPY WIRE BROKE OFF OUTSIDE OF BODY. THIS COULD HAVE BEEN A LIFE-THREATENING EVENT IF THE WIRE BROKE OFF INTO THE PT. THE TIP OF THE WIRE BECAME DETACHED. ALSO THE ROTO LINK SYSTEM BECAME DETACHED FROM THE MOTOR DRIVE UNIT DURING ABLATION PROCEDURE AFTER INSERTED INTO THE BODY. PRODUCT WAS ATTACHED PROPERLY TO MOTOR DRIVE UNIT. ALSO WHEN ATTEMPTING TO DYNA-GLIDE OUT OF THE PT WAS UNABLE TO DO THIS, THE WIRE KEPT SPINNING AND BINDING. USER HAD TO PULL THE WHOLE SYSTEM OUT AND START FROM SCRATCH, REWIRING THE VESSEL, ETC. THIS PRODUCED TENSION, ANXIETY AND PROLONGED PROCEDURE AND CATHETER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE FLOPPY ROTAWIRE DQX HEART TECHNOLOGY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other ADVANCER CATALOG NUMBER 22782-001| BURR, CATALOG NUMBER 22768-002