BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARCATH

    MDR report key: 1143704 · Received August 29, 2008

    Report

    Report Number
    2134265-2008-02483
    Event Type
    Injury
    Date Received
    August 29, 2008
    Report Date
    July 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K022061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 "A MONTH OR SO" POST AN UNSPECIFIED CRYOPLASTY PROCEDURE, THE PT EXPERIENCED "VESSEL SHUTDOWN DUE TO PROGRESSION OF THE DISEASE". IT WAS FURTHER NOTED THAT "VESSEL SHUTDOWN" REFERRED TO RE-STENOSIS. IT WAS NOT KNOWN WHAT TREATMENT WAS PERFORMED. THE PATIENT'S STATUS IS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other