BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 3041485 · Received April 8, 2013

    Report

    Report Number
    2134265-2013-02060
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE EMERGE CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP). THERE WAS BLOOD AND CONTRAST IN THE BALLOON AND INFLATION LUMEN. THE INNER SHAFT WAS KINKED 4MM FROM THE DISTAL EDGE OF THE PROXIMAL MARKERBAND. MAGNIFIED INSPECTION REVEALED A LONGITUDINAL TEAR IN THE BALLOON WALL FROM THE PROXIMAL TO DISTAL END OF THE BALLOON. 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 PROCEDURE, A BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 99% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). AN 15MM X 2.25MM EMERGE BALLOON CATHETER WAS ADVANCED TO THE DISTAL RCA. UPON FIRST INFLATION AT 6 ATMOSPHERES, THERE WERE NO ISSUES NOTED. HOWEVER, AS THE BALLOON WAS INFLATED AT 6 ATMOSPHERES FOR THE SECOND TIME, THE BALLOON RUPTURED. THE DEVICE WAS INTACT WHEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. ACCESS WAS OBTAINED VIA FEMORAL ARTERY. THE 99% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). AN 15MM X 2.25MM EMERGE BALLOON CATHETER WAS ADVANCED TO THE DISTAL RCA. UPON FIRST INFLATION AT 6 ATMOSPHERES, THERE WERE NO ISSUES NOTED. HOWEVER, AS THE BALLOON WAS INFLATED AT 6 ATMOSPHERES FOR THE SECOND TIME, THE BALLOON RUPTURED. THE DEVICE WAS INTACT WHEN REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142780 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919315220 15711232

    Patients

    Seq Age Sex Outcome Treatment
    1