BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 157882 · Received March 20, 1998

    Report

    Report Number
    6000063-1998-00015
    Event Type
    Injury
    Date Received
    March 20, 1998
    Date of Event
    February 17, 1998
    Report Date
    February 20, 1998
    Manufacturer
    SCIMED, A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE DEVICE CONFIRMED THE DISTAL END OF THE GUIDE WIRE PROLAPSED OR WAS PLACED IN A SHARP BEND CAUSING A FATIGUE FAILURE IN THE CORE WIRE. THIS CONDITION IS CONSISTENT WITH DAMAGED CAUSED BY ROTATING THE WIRE WHILE THE DISTAL END OF THE SPRING TIP WAS RESTRAINED.

    Description of Event or Problem · 1

    DURING TREATMENT WITH THE ROTABLATOR SYSTEM, THE GUIDE WIRE FRACTURED AND THE PT WAS SENT TO BYPASS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE ROTATIONAL ANGIOPLASTY GUIDE WIRE DQX SCIMED, A DIVISION OF BOSTON SCIENTIFIC CORP. EX SUP RTW 66887

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention