BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARCATH

    MDR report key: 1172132 · Received September 18, 2008

    Report

    Report Number
    2134265-2008-02722
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K022061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN CONDUCTED A CRYOPLASTY OF THE SUPERFICIAL FEMORAL, POPLITEAL AND POSTERIOR TIBIAL ARTERIES USING A CONTRA LATERAL APPROACH USING A .014-3X100, .035-4X100, AND .035-5X60 POLARCATH BALLOON CATHETERS. THE INFLATION UNIT FOR THE .035X4X100 POLARCATH BALLOON CATHETER ABORTED SEVERAL TIMES DURING THE TREATMENT PHASE. THE INFLATION UNIT WAS EXCHANGED FOR A NEW INFLATION UNIT AND THE TREATMENT PHASE WAS COMPLETED. "AT THE END PROBLEMS RETRIEVING THE CATHETER ENDED BEING A RUPTURE IN THE BALLOON, FILLED WITH BLOOD." THE PROCEDURE WAS COMPLETED WITH A 5X60 POLARCATH BALLOON CATHETER. PATIENT STATUS IS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARCATH DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC M001P4100120010 0000507146

    Patients

    Seq Age Sex Outcome Treatment
    1