BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 705288 · Received April 10, 2006

    Report

    Report Number
    MW1038460
    Event Type
    Other
    Date Received
    April 10, 2006
    Date of Event
    March 30, 2006
    Report Date
    April 10, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS BROUGHT TO THE CATH LAB FOR AN INTERVENTION ON HIS CORONARY ARTERY. DURING P.T. C.A. OF THE L.A.D., THE BALLOON RUPTURED. THE PT EXPERIENCED CHEST PAIN, ECG CHANGES AND HYPOTENSION DURING THE EVENT. IT IS UNKNOWN WHETHER THE SYMPTOMS WERE FROM THE PTCA OR THE BALLOON RUPTURE. THE PROCEDURE WAS STOPPED AT THIS TIME AND THE PT WAS GIVEN FLUID AND PAIN MEDICATION AND WAS WATCHED CAREFULLY UNTIL THE SYMPTOMS "RESIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC NC RANGER BALLOON LOX BOSTON SCIENTIFIC * 8190082

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other