BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR GUIDE WIRE

    MDR report key: 281790 · Received June 13, 2000

    Report

    Report Number
    6000063-2000-00024
    Event Type
    Malfunction
    Date Received
    June 13, 2000
    Date of Event
    May 1, 2000
    Report Date
    May 15, 2000
    Manufacturer
    BOSTON SCIENTIFIC CORP./NW TECHNOLOGY CENTER
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE WITH THE ROTABLATOR DEVICE, THE GUIDE WIRE FRACTURED INSIDE THE PT DURING ABLATION. THE WIRE WAS RETRIEVED WITH A SNARE AND NO PT INJURY OR COMPLICATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR GUIDE WIRE ROTATIONAL ANGIOPLASTY GUIDE WIRE DQX BOSTON SCIENTIFIC CORP./NW TECHNOLOGY CENTER FLOPPY RTW 2868761

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention