BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 2234123 · Received September 6, 2011

    Report

    Report Number
    2134265-2011-03941
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 12 X 3.50MM APEX MONORAIL BALLOON CATHETER WAS ADVANCED TO THE TARGET LESION. THE DEVICE WAS INFLATED TO 12ATM FOR 40 SECONDS ON THE FIRST INFLATION THEN BURST AT 12ATM AFTER 40 SECONDS ON THE SECOND INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY H7493895912350 13895757

    Patients

    Seq Age Sex Outcome Treatment
    1