BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFLATION UNIT

    MDR report key: 1811717 · Received August 23, 2010

    Report

    Report Number
    2134265-2010-03601
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    DQY
    PMA / PMN Number
    K022061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFLATION UNIT WAS RECEIVED BACK IN OVER ALL GOOD PHYSICAL CONDITION. AS RECEIVED, ALL LED WERE ILLUMINATED AND FLASHING. THE INFLATION UNIT WAS PLUGGED INTO THE DOWNLOAD COMPUTER AND THE DOWNLOADED DATA INDICATED THAT A VENTLEAKCHECKFAIL ERROR HAD OCCURRED. THE INFLATION UNIT WAS RESET AND CONNECTED TO A TEST CATHETER AND DURING FUNCTIONAL TESTING THE UNIT COMPLETED FOUR COMPLETE TREATMENT CYCLES WITH NO ERRORS. THERE WERE NO OCCURRENCES OF THE SYSTEM ACTIVATING AUTOMATICALLY DURING OUR TESTING. VISUAL INSPECTION OF THE TOP AND BOTTOM ENCLOSURES REVEALED NO VISUAL DAMAGES. THE INFLATION UNIT WAS DISASSEMBLED AND THE PCB WAS VISUALLY INSPECTED AND VERIFIED NORMAL. THE INFLATION UNIT OPERATED WITHIN SPECIFICATIONS WITH NO ERRORS IDENTIFIED. WE WERE UNABLE TO REPLICATE THE CUSTOMER¿S COMPLAINT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CRYOPLASTY TREATMENT PROCEDURE; THE INFLATION UNIT STARTED BY ITSELF. THE APPROXIMATELY 70% STENOTIC LESION WAS LOCATED IN THE 6MM NON TORTUOUS AND NON CALCIFIED PULMONARY VEIN. THE POLARCATH BALLOON WAS IN PLACE, NEGATIVE HAD BEEN PULLED AND WHEN THEY WENT TO SCREW THE NITROUS OXIDE CARTRIDGE INTO THE POLARCATH DILATATION INFLATION UNIT, THE INFLATION UNIT STARTED WITHOUT TOUCHING THE START BUTTON. THEY HEARD THE STARTING NOISES AND THE BALLOON VERY SLIGHTLY INFLATED. THE BALLOON WAS POSITIONED CORRECTLY AND DIDN'T INFLATE ENOUGH FOR ANY CLINICAL ISSUES TO TRANSPIRE. THE SYSTEM QUICKLY DEACTIVATED AND INDICATED REPLACEMENT OF THE INFLATION UNIT. THE PROCEDURE WAS COMPLETED WITH A NEW INFLATION UNIT. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS REPORTED AS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATION UNIT CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - SAN JOSE M001PCIU400000 12825648

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR POLARCATH BALLOON CATHETER