BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE BALLOON CATHETER INFLATION DEVICE

    MDR report key: 3932149 · Received July 14, 2014

    Report

    Report Number
    2134265-2014-04204
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MAV
    PMA / PMN Number
    K120694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. THE UNIT WAS VISUALLY INSPECTED FOR ANY DAMAGE OR DEFECT. THE GAUGE NEEDLE OF THE RETURNED DEVICE WAS BELOW THE 0 ATM MARK. THE RETURNED GAUGE WAS REPLACED WITH A TEST GAUGE. THE UNIT THEN PASSED ALL FUNCTIONAL TESTS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT A BROKEN BARREL OCCURRED. A 26 ADVANTAGE BALLOON CATHETER INFLATION DEVICE WAS SELECTED AND USED TO INFLATE A BALLOON CATHETER. UPON INFLATION, AN ABNORMAL SOUND WAS NOTED AND IT LOOK LIKE THE SYRINGE WAS GOING TO BREAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. HOWEVER, DEVICE ANALYSIS REVEALED THE GAUGE READING WAS BELOW 0ATM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409128 ADVANTAGE BALLOON CATHETER INFLATION DEVICE SYRINGE, BALLOON INFLATION MAV BOSTON SCIENTIFIC - CORK H74904527011 0016658523

    Patients

    Seq Age Sex Outcome Treatment
    1