BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARCATH

    MDR report key: 1991909 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00197
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    DQY
    PMA / PMN Number
    K022061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: (B)(6) YEARS. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 70% STENOTIC LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED EXTERNAL ILIAC. THE PHYSICIAN ADVANCED THE .035:6.0MM POLARCATH BALLOON TO THE LESION AND BEGAN THE TREATMENT CYCLE AND THEN ALL OF THE ERROR LIGHTS ON THE POLARCATH INFLATION UNIT CAME ON. THE INFLATION UNIT WAS EXCHANGED FOR A NEW ONE AND AN ATTEMPT WAS MADE TO RUN ANOTHER TREATMENT CYCLE BUT THE CHECK CATHETER LIGHT CAME ON. THE PROCEDURE WAS COMPLETED WITH ANOTHER .035:6.0MM POLARCATH BALLOON. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS OK. THE PHYSICIAN BELIEVES THAT THE SHORT TREATMENT CYCLE WAS DUE TO A BALLOON RUPTURE, BUT IT IS UNKNOWN IF THE RUPTURE OCCURRED IN THE INNER OR OUTER BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARCATH CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - SAN JOSE M001P6100120010 13522179

    Patients

    Seq Age Sex Outcome Treatment
    1 POLARCATH INFLATION UNIT