BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2140258 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02790
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    March 31, 2011
    Report Date
    June 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K955869
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED WITH THE GAUGE UNATTACHED. THE DEVICE HOUSING WAS SPLIT. THE DEVICE WAS DISASSEMBLED AND A BENT AND MISALIGNED TAB WAS NOTED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING. BSC ID: A00276884 TW: 2027450

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY AND STENTING TREATMENT PROCEDURE, A CRACKED GAUGE COVER OCCURRED. THE PRESSURE GAUGE COVER CRACKED ON THIS ADVANTAGE 26 INFLATION DEVICE WHEN POSITIVE PRESSURE WAS APPLIED. THE DEVICE WAS NOT ABLE TO INFLATE AT ALL. THERE WERE NO COMPLICATIONS WITH ANY CONCOMITANT DEVICE ATTACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ADVANTAGE 26 DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE PRESSURE GAUGE DETACHED FROM THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904526011

    Patients

    Seq Age Sex Outcome Treatment
    1