BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAROTID SHUNT 11FR. SIL.BALLOON W/CHECKVALVE

    MDR report key: 2123705 · Received June 14, 2011

    Report

    Report Number
    3008500478-2011-00107
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 10, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DWF
    PMA / PMN Number
    K860497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BALLOON WOULDN'T INFLATE.

    Additional Manufacturer Narrative · 1

    "EDWARDS (B)(4) EVALUATION AND INVESTIGATION: THE BALLOON INFLATION DIFFICULTY REPORTED WITH THE (B)(4) DEVICE WAS CONFIRMED BY ENGINEERING. THE 15 MM BALLOON DID NOT INFLATE WHEN NORMAL FORCE WAS APPLIED TO THE PLUNGER OF A 3 ML SYRINGE SEATED TO THE BLUE VALVE. EXCESS FORCE WAS APPLIED TO THE SYRINGE PLUNGER AND THE BALLOON INFLATED; HOWEVER ONCE INFLATED, THE BALLOON WOULD NOT DEFLATE NORMALLY. THE 9 MM BALLOON INFLATED NORMALLY WHEN INFUSED WITH 1 ML OF AIR WITH A 1 ML SYRINGE SEATED TO THE WHITE VALVE. DEFLATION OF THE 9 MM BALLOON WAS ACCOMPLISHED NORMALLY USING THE 1 ML SYRINGE. THIS EVENT DID NOT LEAD TO THRESHOLD BEING EXCEEDED WITHIN THE TREND REPORT FOR CAROTID SHUNTS, THEREFORE, A CAPA WILL NOT BE INITIATED. THE INFORMATION WILL BE INCLUDED IN TREND DATA AND FUTURE CAPA DETERMINATIONS. THE (B)(4) MANUFACTURING PROCESS AND ACCEPTANCE ACTIVITIES REMAIN APPROPRIATE AND ALL PLANNED ACTIVITIES ASSOCIATED WITH THE MANUFACTURE AND TESTING OF THE (B)(4) DEVICES ARE ACCEPTABLE.

    Description of Event or Problem · 1

    AS REPORTED, THE SURGEON TRIED TO USE THE DEVICE AND THE BALLOON WOULDN'T INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAROTID SHUNT 11FR. SIL.BALLOON W/CHECKVALVE CAROTID SHUNT DWF EDWARDS LIFESCIENCES T3103B 58900601

    Patients

    Seq Age Sex Outcome Treatment
    1