BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDI-TECH (BOSTON SCIENTIFIC CORP.)

    MDR report key: 167571 · Received May 5, 1998

    Report

    Report Number
    MW1013788
    Event Type
    Injury
    Date Received
    May 5, 1998
    Date of Event
    April 28, 1998
    Report Date
    May 4, 1998
    Manufacturer
    BOSTON SCIENTIC CORP.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING ATTEMPTED PALMAZ STENT PLACEMENT WITH A PROPERLY POSITIONED AND CRIMPED STENT, NORMAL INFLATION OF THE MEDITECH BALLOON CAUSED DISPLACEMENT OF THE STENT WITHOUT DISTENDING THE STENT ENOUGH TO ALLOW RECAPTURE OF THE STENT. THIS OCCURRED DURING EACH OF TWO SUCCESSIVE ATTEMPTS AT STENT DEPLOYMENT WITH THE 2ND EVENT RESULTING IN THE STENT BEING COMPLETELY DISPLACED FROM THE BALLOON CATHETER ONTO THE GUIDE WIRE WITH JUST ENOUGH EXPANSION OF THE PROXIMAL STENT TO PREVENT EASY RETRIEVAL THROUGH A SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-TECH (BOSTON SCIENTIFIC CORP.) ULTRA-THIN DIAMOND DILATATION CATHETER LIT BOSTON SCIENTIC CORP. * 1260996

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention