BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE GUIDEWIRE

    MDR report key: 126527 · Received October 16, 1997

    Report

    Report Number
    6000054-1997-00002
    Event Type
    Injury
    Date Received
    October 16, 1997
    Date of Event
    August 11, 1997
    Report Date
    September 25, 1997
    Manufacturer
    MEDI-TECH TERUMO MEDICAL CORP
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS DISTRIBUTOR BECAME AWARE ON SEPTEMBER 25, 1997 OF AN INCIDENT THAT OCCURRED INVOLVING A GLIDEWIRE DURING A THOMBOLYSIS PROCEDURE. THE GUIDEWIRE REPORTEDLY BROKE OFF IN THE PATIENT'S ARM. THE PATIENT WAS BROUGHT TO SURGERY WHERE THE WIRE WAS SUCCESSFULLY REMOVED AND AN OPEN FISTULA WAS PERFORMED. THERE WAS NO PATIENT COMPLICATIONS INVOLVED. NO FURTHER DETAILS ARE AVAILABLE WITH REGARDS TO THE CIRCUMSTANCES SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDEWIRE GUIDEWIRE GUIDEWIRE DQX MEDI-TECH TERUMO MEDICAL CORP NA 961107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention