BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 2221226 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03478
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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. DEVICE EVALUATED BY MFR: 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 (PCI) TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 12X3.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO THE LESION FOR POST-DILATION OF A 3.50X23MM NON-BSC STENT AND IT RUPTURED AT 20 ATMS AFTER 30 SECONDS ON THE FIRST INFLATION. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 - MAPLE GROVE H7493895912370

    Patients

    Seq Age Sex Outcome Treatment
    1 3.5X23MM XIENCE V STENT| ABBOTT COPILOT INFLATION DEVICE