BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 1588024 · Received January 19, 2010

    Report

    Report Number
    1588024
    Event Type
    Malfunction
    Date Received
    January 19, 2010
    Date of Event
    December 18, 2009
    Report Date
    January 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CARDIOLOGIST PERFORMING PROCEDURE USING ROTOCATHETER. HE REPORTS THE FOOT PEDAL WAS DEFECTIVE AND WOULDN'T ACTIVATE THE ROTOCATHETER, SO ROTOCATHETER WAS NOT INSERTED INTO PT. PROCEDURE CANCELLED. NEXT DAY, PROCEDURE PERFORMED AND PT DIED IN THE CATH LAB. THE DOCTOR BELIEVES THE PT HAD A MASSIVE HEART ATTACK. (B)(4) (PRODUCT ANALYST II) IN POST MARKET SURVEILLANCE WITH BOSTON SCIENTIFIC MADE AWARE OF INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC FOOT PEDAL MCX BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other