BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GATEWAY PTA DILATION CATHETER

    MDR report key: 1231631 · Received November 14, 2008

    Report

    Report Number
    2939204-2008-00584
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 27, 2008
    Report Date
    November 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOR NO ALLEGATION OF PRODUCT MALFUNCTION OR NON CONFORMANCE CONTRIBUTING TO THE REPORTED EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY AND THE LESION HAD GREATER THAN 50% STENOSIS BUT NO CALCIFICATION. BEFORE AND AFTER THE PROCEDURE THE PATIENT WAS PRESCRIBED ASPIRIN AND PLAVIX. THE "REAPROT" DRIP WAS PRESCRIBED IN ADDITION DUE TO THE PROCEDURAL THROMBOSIS. THE PHYSICIAN DID NOT ALLEGE ANY MALFUNCTION OR NON CONFORMANCE OF THE DEVICE OCCURRED.

    Description of Event or Problem · 1

    FOLLOWING ANGIOPLASTY TO TREAT LESION IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA), M1 SEGMENT, A THROMBUS WAS NOTED TO FORM. THE PHYSICIAN ADMINISTERED "REAPROT" INTRAVENOUSLY DURING THE PROCEDURE AND THE PATIENT WAS PLACED ON A "REAPROT" DRIP POST PROCEDURE. THE DRIP WAS DISCONTINUED DURING THE NIGHT DUE TO A DROP IN PRESSURE, THE CAUSE OF WHICH WAS UNKNOWN. THE FOLLOWING DAY, THE THROMBUS OCCLUDED THE DISTAL MCA, M2 SEGMENT TO TREATED M1 SEGMENT. THE THROMBUS RESOLVED AND THE PATIENT WAS REPORTED TO BE STABLE WITH NO LASTING IMPAIRMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention