BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 2980876 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-01030
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 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

    DEVICE EVALUATED BY MFR.: THERE WAS BLOOD AND CONTRAST IN THE BALLOON AND INFLATION LUMEN. 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. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING 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 RUPTURE OCCURRED. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. USING A 7F MACH1 GUIDE CATHETER AND A NON-BSC GUIDE WIRE, THE PHYSICIAN ADVANCED A 15 MM X 2.50 MM EMERGE MR BALLOON CATHETER TO THE TARGET LESION. UPON INFLATION AT 10 ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY. USING A 7F MACH1 GUIDE CATHETER AND A NON-BSC GUIDE WIRE, THE PHYSICIAN ADVANCED A 15MM X 2.50MM EMERGE MR BALLOON CATHETER TO THE TARGET LESION. UPON INFLATION AT 10ATMS THE BALLOON RUPTURED. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84824 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919308120 15653318

    Patients

    Seq Age Sex Outcome Treatment
    1 SION BLUE GUIDE WIRE| 7F MACH1 AL1 SH GUIDE CATHETER