BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GATEWAY BALLOON CATHETER

    MDR report key: 2063285 · Received April 19, 2011

    Report

    Report Number
    2939204-2011-00221
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    GBA
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. STROKE IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ONE DAY POST PROCEDURE THE PATIENT SUFFERED A MINOR STROKE WITH LACUNAR INFARCTION IN THE RIGHT CEREBELLAR HEMISPHERE AND IN THE VERMIS CEREBELLI IN THE TERRITORY OF THE TREATED VESSEL (BASILAR ARTERY). THE STROKE RESOLVED WITH RESIDUAL SEQUELAE OF LATENT RIGHT HEMIPARESIS AND A LIMPING GAIT.

    Description of Event or Problem · 1

    ONE DAY POST PROCEDURE THE PATIENT SUFFERED A MINOR STROKE WITH LACUNAR INFARCTION IN THE RIGHT CEREBELLAR HEMISPHERE AND IN THE VERMIS CEREBELLI IN THE TERRITORY OF THE TREATED VESSEL (BASILAR ARTERY). THE STROKE RESOLVED WITH RESIDUAL SEQUELAE OF LATENT RIGHT HEMIPARESIS AND A LIMPING GAIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GATEWAY BALLOON CATHETER CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MAPLE GROVE M0032072409300

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other GATEWAY BALLOON (BOSTON SCIENTIFIC)| WINGSPAN STENT YSTEM (BOSTON SCIENTIFIC)