BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MONORAIL

    MDR report key: 1000140 · Received February 19, 2008

    Report

    Report Number
    2134265-2008-00484
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE AND A VESSEL RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED DISTAL LEFT CIRCUMFLEX (LCX). A NON BSC GUIDE WIRE WAS ADVANCED TO THE LESION AND WAS PREDILATED BY A 1.5MM APEX BALLOON. THE PHYSICIAN THEN CHANGED THE APEX BALLOON TO A 2.00X12MM APEX BALLOON WHICH RUPTURED AT 8 ATM. THE PHYSICIAN ALSO NOTED THAT CONTRAST MATERIAL LEAKED FROM THE PROXIMAL BOND SIDE OF THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. DURING THE PROCEDURE A "TINY VESSEL RUPTURE" OCCURRED AND CAUSED BLEEDING AND BLOOD FLOW TO BECOME WORSE. THE VESSEL DAMAGE WAS TREATED BY A NON BSC STENT AND IT WAS NOTED THAT THE PATIENT'S CONDITION IMPROVED AFTER THE TREATMENT. THE PATIENT'S CURRENT CONDITION IS LISTED AS "STABLE." THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL PTCA DILATATION CATHETER LOX BOSTON SCIENTIFIC 2.00X12MM 11313177

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention VOYAGER 20.X15MM BALLOON| NEOS CONQUEST PRO GUIDE WIRE