BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRIEVER-18

    MDR report key: 218001 · Received April 2, 1999

    Report

    Report Number
    6000078-1999-00024
    Event Type
    Malfunction
    Date Received
    April 2, 1999
    Date of Event
    August 3, 1998
    Report Date
    April 2, 1999
    Manufacturer
    TARGET THERAPEUTICS / A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED TO TARGET THAT WHILE ATTEMPTING TO REMOVE A STENT, THE RETRIEVER LOOP COULD NOT BE SHAPED. UPON EVALUATION OF THE DEVICE, IT WAS FOUND THAT THE CORE WIRE WAS BROKEN AND PERFORATED THE CATHETER, THEREFORE THIS COMPLAINT BECAME A MDR. FROM A FOLLOW-THROUGH WITH A HOSPITAL REP ON 03/30/1999, TARGET WAS INFORMED THAT THERE WERE NO COMPLICATIONS TO THE PT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETRIEVER-18 ENDOVASCULAR SNARE DQO TARGET THERAPEUTICS / A DIVISION OF BOSTON SCIENTIFIC CORP. NA A63723

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO