BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE¿

    MDR report key: 3011169 · Received March 19, 2013

    Report

    Report Number
    2134265-2013-01512
    Event Type
    Malfunction
    Date Received
    March 19, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 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: THERE WAS BLOOD 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 5MM FROM THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. THE BALLOON PRESENTED NO IRREGULARITIES IN THE BALLOON MATERIAL OR THE RO MARKER. 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. THE LESION WAS LOCATED IN A MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.50MM X 15MM EMERGE BALLOON CATHETER WAS BEING USED FOR POST-DILATATION WHEN IT RUPTURED AT UNKNOWN ATMS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN A MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. THE 2.50MM X 15MM EMERGE BALLOON CATHETER WAS BEING USED FOR POST-DILATATION WHEN IT RUPTURED AT UNKNOWN ATMS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113329 EMERGE¿ CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493919315250 15663425

    Patients

    Seq Age Sex Outcome Treatment
    1