BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GATEWAY PTA BALLOON

    MDR report key: 1221873 · Received November 4, 2008

    Report

    Report Number
    2939204-2008-00551
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 16, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER FOR VESSEL DISSECTION. NO ALLEGATION OF DEVICE MALFUNCTION OR NONCONFORMANCE CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT PRESENTED WITH "MODERATELY SEVERE" STENOSIS OF THE PROXIMAL BASILAR ARTERY AND WAS SCHEDULED TO UNDERGO INTRACRANIAL ANGIOPLASTY AND STENTING. THE STENOSIS WAS DILATED WITH A PTA BALLOON, INFLATED TO NOMINAL PRESSURE. FOLLOWING THE ANGIOPLASTY, A SMALL DISSECTION WAS NOTED. THE PHYSICIAN PROCEEDED TO PLACE THE STENT AS PLANNED. PATIENT IS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY PTA BALLOON (GBA) DILATATION BALLOON CATHETER GBA NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP 20720-1525

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR WINGSPAN STENT (BOSTON SCIENTIFIC)