BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENTRY BALLOON CATHETER

    MDR report key: 572432 · Received February 8, 2005

    Report

    Report Number
    6000078-2004-00247
    Event Type
    Malfunction
    Date Received
    February 8, 2005
    Date of Event
    December 16, 2004
    Report Date
    February 4, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    MJN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS NOTIFIED THAT DURING AN EVENT AFTER NAVIGATION OF THE SENTRY BALLOON CATHETER TO THE MID CERVICAL ICA, WHERE A DISSECTING PSEUDO ANEURYSM WAS LOCATED, IMMEDIATELY AFTER A CALCIFIED PLAQUE, IT WAS STARTED TO BE INFLATED. THE REASON AS TO WHY THE BALLOON WAS INFLATED AT THIS LOCATION WAS DUE TO THE CONCORDANCE OF THE VESSEL DIAMETER WITH THE BALLOON DIAMETER AT THAT LOCATION. DURING INFLATION, THE DISTAL EDGE OF THE BALLOON STARTED TO FAG PAST THE TIP OF THE CATHETER. THEN THE BALLOON WAS DEFLATED AND WITHDRAWN QUICKLY. NO COMPLICATIONS WERE REPORTED TO HAVE OCCURRED WITH THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENTRY BALLOON CATHETER OCCLUSION BALLOON CATHETER MJN BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION * 5581497

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR