BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3103247 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03101
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE EMERGE CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP) WITHIN AN EMERGE SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. THERE WAS BLOOD IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED A PINHOLE 2MM FROM THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON BURST OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A 20MM X 2.50MM EMERGE BALLOON CATHETER WAS ADVANCED TO THE TARGET VESSEL FOR PREDILATION. UPON FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATM. THE DEVICE WAS THEN REPLACED WITH A DIFFERENT DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS LISTED AS "FINE".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON BURST OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE MILDLY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A 20MM X 2.50MM EMERGE BALLOON CATHETER WAS ADVANCED TO THE TARGET VESSEL FOR PREDILATION. UPON FIRST INFLATION, THE BALLOON RUPTURED AT 12 ATM. THE DEVICE WAS THEN REPLACED WITH A DIFFERENT DEVICE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS LISTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204542 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493918920250 15787220

    Patients

    Seq Age Sex Outcome Treatment
    1