BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE?

    MDR report key: 3161785 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-04042
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 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

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS RECEIVED INSIDE AN EMERGE SHELF BOX THAT MATCHED THE INFORMATION ON THE DEVICE. THERE WAS A STOPCOCK ATTACHED TO THE INFLATION PORT. MAGNIFIED INSPECTION REVEALED A PINHOLE IN THE BALLOON WALL ALIGNED WITH THE 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN USED A 1.20MM X 8MM EMERGE BALLOON CATHETER TO CROSS THE LESION SUCCESSFULLY. HOWEVER, UPON FIRST INFLATION, THE BALLOON RUPTURED AT 8ATMS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN USED A 1.20MM X 8MM EMERGE BALLOON CATHETER TO CROSS THE LESION SUCCESSFULLY. HOWEVER, UPON FIRST INFLATION, THE BALLOON RUPTURED AT 8ATMS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262855 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919308120 15814448

    Patients

    Seq Age Sex Outcome Treatment
    1