BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3012119 · Received March 20, 2013

    Report

    Report Number
    2134265-2013-01631
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 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 AND THERE WAS CONTRAST MEDIA IN THE BALLOON AND INFLATION LUMEN. MAGNIFIED INSPECTION REVEALED NO DAMAGE. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, A STREAM OF WATER EMITTED FROM A PINHOLE 3MM 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. 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

    AGE AT TIME OF EVENT - (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A SMALL HOLE WAS OBSERVED IN THE BALLOON. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED TARGET LESIONS WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ECCENTRIC LEFT ANTERIOR DESCENDING ARTERY (LAD) AND RIGHT CORONARY ARTERY (RCA). A 20MM X 2.50MM EMERGE MR BALLOON WAS INSERTED INTO ONE OF THE STENOSIS. WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON, HE WAS NOT ABLE RAISE THE PRESSURE TO INFLATE. HE REMOVED THE BALLOON AND HE NOTICED THAT THE CONTRAST MEDIA WAS COMING OUT OF A SMALL HOLE OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER EMERGE MR BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A SMALL HOLE WAS OBSERVED IN THE BALLOON. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED TARGET LESIONS WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ECCENTRIC LEFT ANTERIOR DESCENDING ARTERY (LAD) AND RIGHT CORONARY ARTERY (RCA). A 20MM X 2.50MM EMERGE MR BALLOON WAS INSERTED INTO ONE OF THE STENOSIS. WHEN THE PHYSICIAN ATTEMPTED TO INFLATE THE BALLOON, HE WAS NOT ABLE RAISE THE PRESSURE TO INFLATE. HE REMOVED THE BALLOON AND HE NOTICED THAT THE CONTRAST MEDIA WAS COMING OUT OF A SMALL HOLE OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER EMERGE MR BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116333 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919320250 15768243

    Patients

    Seq Age Sex Outcome Treatment
    1