BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 1220271 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04182
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 10, 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

    DEVICE EVALUATION: PRODUCT ANALYSIS CONFIRMED THE DIFFICULTY STATED IN THE COMPLAINT. A VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON IDENTIFIED ONE PINHOLE LOCATED AT THE DISTAL MARKER BAND OF THE BALLOON. THE RETURNED DEVICE WAS CONNECTED TO AN ENCORE INFLATION UNIT, IN AN ATTEMPT TO INFLATE LIQUID INTO THE BALLOON AND IDENTIFY IF ANY LEAKS WERE PRESENT. THE INFLATION DEVICE WAS SLOWLY PRESSURIZED TO THE NOMINAL PRESSURE OF 6 ATMOSPHERES (ATM) FOR 60 SECONDS AND AGAIN AT 12 ATM FOR 60 SECONDS. THE BALLOON PINHOLE WAS THEN IDENTIFIED. NO KINKS OR DAMAGE WERE NOTICED ALONG THE SHAFT OF THE DEVICE. THE TIP SECTION OF THE DEVICE WAS SLIGHTLY FLARED. ATTEMPTS TO INSERT THE RECOMMENDED SIZE PRODUCT MANDREL (0.015 INCH) WERE UNSUCCESSFUL, DUE A KINK PRESENT IN THE INNER LUMEN 3MM PROXIMAL TO THE DISTAL MARKERBAND. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS DETERMINED TO BE OPERATIONAL CONTEXT, DUE TO THE ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN ADVANCED THE 2.25X12MM APEX BALLOON CATHETER TO THE LESION AND INFLATED THE BALLOON TO 12 ATMS, AND IT RUPTURED. THERE WERE NO PT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE. PT STATUS IS REPORTED AS "GOOD". THIS DEVICE IS ONLY OUS APPROVED, BUT IS SIMILAR TO MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC 2.25X12 MM 11380287

    Patients

    Seq Age Sex Outcome Treatment
    1