BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 2020674 · Received March 16, 2011

    Report

    Report Number
    2134265-2011-00649
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K875064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ZA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED NO DEFECTS. FUNCTIONAL TESTING WAS PERFORMED AND THE INFLATION UNIT AND PRESSURE GAUGE MET SPECIFICATIONS. THE BATCH NUMBER IS UNKNOWN; THEREFORE THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED PRIOR TO PATIENT CONTACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTA REPAIR PROCEDURE, THE PRESSURE GAUGE READ INACCURATELY. THE PLUNGER OF THE ENCORE 26 INFLATION DEVICE WAS DEPRESSED TO UNLOCK THE THREADED PLUNGER. THE PLUNGER WAS PULLED BACK AND 5 - 8ML OF THE CONTRAST MIXTURE WAS ASPIRATED INTO THE SYRINGE AND THE DEVICE WAS HELD UPRIGHT TO ELIMINATE ANY AIR. THE CONNECTING TUBE WAS ATTACHED TO THE BALLOON LUER PORT AND THE FINGER LATCH WAS LOCKED IN A CLOCKWISE DIRECTION. THE PRESSURE WAS INCREASED, BUT THE NEEDLE ON THE PRESSURE GAUGE DID NOT MOVE AND THE PRESSURE READ ZERO. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE 26 INFLATION DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR AN AORTA REPAIR PROCEDURE, THE PRESSURE GAUGE READ INACCURATELY. THE PLUNGER OF THE ENCORE 26 INFLATION DEVICE WAS DEPRESSED TO UNLOCK THE THREADED PLUNGER. THE PLUNGER WAS PULLED BACK AND 5 - 8ML OF THE CONTRAST MIXTURE WAS ASPIRATED INTO THE SYRINGE AND THE DEVICE WAS HELD UPRIGHT TO ELIMINATE ANY AIR. THE CONNECTING TUBE WAS ATTACHED TO THE BALLOON LUER PORT AND THE FINGER LATCH WAS LOCKED IN A CLOCKWISE DIRECTION. THE PRESSURE WAS INCREASED, BUT THE NEEDLE ON THE PRESSURE GAUGE DID NOT MOVE AND THE PRESSURE READ ZERO. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENCORE 26 INFLATION DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK M001151050

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR