BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MONORAIL

    MDR report key: 1040495 · Received May 9, 2008

    Report

    Report Number
    2134265-2008-01356
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    LOX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A VESSEL PERFORATION OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND TORTUOUS MARGINAL CIRCUMFLEX (CX). DURING INFLATION THE 2.0 X 20 MM APEX MONORAIL BALLOON CATHETER PINHOLED ON A SHARP PLAQUE DURING INFLATION AT 16 ATMS AFTER TWO TO THREE SECONDS CAUSING A VESSEL PERFORATION. THE BALLOON WAS REMOVED AND TWO NON BSC STENTS WERE IMPLANTED TO SUCCESSFULLY TREAT THE PERFORATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PT COMPLICATIONS REPORTED. THE PT'S CURRENT CONDITION IS LISTED AS "STABLE." THIS PRODUCT IS ONLY OUS APPROVED BUT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC CORP. 2.0X20MM 11262762

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention