BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1953703 · Received January 10, 2011

    Report

    Report Number
    2134265-2010-05876
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DESCRIBE EVENT OR PROBLEM: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 75% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS PROXIMAL RCA (RIGHT CORONARY ARTERY). A GUIDE WIRE WAS SUCCESSFULLY ADVANCED ACROSS THE LESION. THE 3.5X12MM APEX BALLOON WAS ADVANCED FOR PREDILATION OF THE LESION BUT COULD NOT CROSS. A PARALLEL WIRE TECHNIQUE WAS USED AND THE APEX BALLOON CROSSED THE LESION. THE BALLOON WAS INFLATED TO 4ATM AND BLOOD WAS NOTED IN THE INFLATION DEVICE. THE APEX BALLOON WAS REMOVED FROM THE PATIENT INTACT AND A LONGITUDINAL RUPTURE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 12761420

    Patients

    Seq Age Sex Outcome Treatment
    1