BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX PUSH MONORAIL

    MDR report key: 1230414 · Received November 7, 2008

    Report

    Report Number
    2134265-2008-04269
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT 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, A BALLOON RUPTURE OCCURRED. THE DETAILS OF THE LESION ARE UNKNOWN. A MACH1 GUIDE CATHETER WAS USED. ON THE 2ND INFLATION, A 1.5X15MM APEX PUSH MONORAIL BALLOON WAS INFLATED FOR APPROXIMATELY 5 SECONDS AT 12 ATMOSPHERES AND RUPTURED. PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. PATIENT'S STATUS IS GOOD WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX PUSH MONORAIL NA LOX BOSTON SCIENTIFIC 1.5X15 MM 11130228

    Patients

    Seq Age Sex Outcome Treatment
    1 GW: CONQUEST