BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1448529 · Received June 8, 2009

    Report

    Report Number
    2134265-2009-02671
    Event Type
    Malfunction
    Date Received
    June 8, 2009
    Date of Event
    May 11, 2009
    Report Date
    May 11, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    P030025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: P860019/S208. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE UNSPECIFIED TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS UNK ARTERY. AN APEX MONORAIL 20 MM X 2.00 MM BALLOON CATHETER WAS SELECTED AND ADVANCED TO TREAT THE TARGET LESION. DURING THE PROCEDURE, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERET DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC 2.0X20 MM 12035951

    Patients

    Seq Age Sex Outcome Treatment
    1