BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARCATH

    MDR report key: 1230029 · Received November 12, 2008

    Report

    Report Number
    2953184-2008-00040
    Event Type
    Injury
    Date Received
    November 12, 2008
    Report Date
    October 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K022061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ABOUT SIX MONTHS AFTER A CRYOPLASTY PROCEDURE ON THE POPLITEAL ARTERY AND SUPERFICIAL FEMORAL ARTERY, THE PT RETURNED FOR FURTHER TREATMENT. THE PT HAD ANOTHER ANGIOPLASTY AS THE DISEASE WAS MUCH MORE SEVERE THAN PRE-CRYOPLASTY. SIZE OF THE POLARCATH BALLOON CATHETERS USED 5MM, 4MM AND 3MM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other