BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLIDEWIRE ANGLED TYPE

    MDR report key: 19128 · Received June 16, 1994

    Report

    Report Number
    1219544-1994-00023
    Event Type
    Injury
    Date Received
    June 16, 1994
    Date of Event
    May 17, 1994
    Report Date
    June 1, 1994
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON MAY 18, 1994 AN INCIDENT OCCURRED WHILE PERFORMING A SUPERFICIAL FEMORAL ANGIOPLASTY INVOLVING A GLIDE WIRE. THE GLIDE WIRE HAD NOT BEEN USED AS THE PRIMARY WIRE. ADVANCEMENT THROUGH A TOTAL OCCLUSION WAS MET WITH RESISTANCE. AFTER MUCH MANIPULATION THE PHYSICIAN ATTEMPTED TO REMOVE THE GLIDE WIRE. UPON REMOVAL OF THE WIRE FROM THIS OCCLUDED ARTERY 40-50 CM OF THE DISTAL END OF THE WIRE BROKE OFF IN THE PT;S LEFT EXTERNAL ILIAC ARTERY. RETRIEVAL ATTEMPTS WERE MADE WITH A SNARE BUT WERE UNSUCCESSFUL. SUCCESSFUL SURGICAL REMOVAL OF THE DETACHED WIRE SEGMENT FOLLOWED. THE PT HAD EXPERIENCED NO SEQUELAE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLIDEWIRE ANGLED TYPE GLIDEWIRE DQX TERUMO MEDICAL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention