BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3150525 · Received June 6, 2013

    Report

    Report Number
    2134265-2013-03882
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 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 MANUFACTURER: THE EMERGE CATHETER WAS RECEIVED INSIDE A CARRIER TUBE (HOOP) WITHIN AN EMERGE SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. MAGNIFIED INSPECTION REVEALED NO DAMAGE. THE DEVICE WAS INFLATED TO RATED BURST PRESSURE (RBP) WITH AN INFLATION DEVICE FILLED WITH WATER. THE DEVICE MAINTAINED RBP FOR FIVE (5) MINUTES WITH NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. THE DEVICE WAS DEFLATED BY APPLYING NEGATIVE PRESSURE WITH THE INFLATION DEVICE. FUNCTIONAL TESTING REVEALED NO EVIDENCE OF THE ALLEGED BALLOON BURST. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS NOT CONFIRMED. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL END OF LEFT CIRCUMFLEX ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED AND THE BALLOON WAS INFLATED FOUR TIMES: ON FIRST INFLATION AT 6 ATMOSPHERES, ON SECOND INFLATION AT 10 ATMOSPHERES, ON THIRD INFLATION AT 18 ATMOSPHERES BUT IT RUPTURED ON THE FOURTH INFLATION AT 16 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PERCUTANEOUS CORONARY INTERVENTION, BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL END OF LEFT CIRCUMFLEX ARTERY. A 1.20MM X 8MM EMERGE BALLOON CATHETER WAS ADVANCED AND THE BALLOON WAS INFLATED FOUR TIMES: ON FIRST INFLATION AT 6 ATMOSPHERES, ON SECOND INFLATION AT 10 ATMOSPHERES, ON THIRD INFLATION AT 18 ATMOSPHERES BUT IT RUPTURED ON THE FOURTH INFLATION AT 16 ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250384 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919308120 15814757

    Patients

    Seq Age Sex Outcome Treatment
    1