BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARCATH

    MDR report key: 1220287 · Received November 3, 2008

    Report

    Report Number
    2134265-2008-04194
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    August 21, 2008
    Report Date
    October 9, 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 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 MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED DIFFICULTY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2008-02722. IT WAS REPORTED THAT DURING A CRYOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE PHYSICIAN PERFORMED 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 .035-4X100 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. PT STATUS IS REPORTED AS "STABLE". IT WAS FURTHER REPORTED THAT THE 5/60 POLARCATH BALLOON CATHETER WAS USED IN THE 50% STENOTIC LESION IN THE NON-TORTUOUS AND MILDLY CALCIFIED DISTAL SUPERFICIAL FEMORAL ARTERY. AFTER SUCCESSFULLY COMPLETING THE TREATMENT PHASE, THE BALLOON WOULD NOT COMPLETELY DEFLATE. THERE WAS DIFFICULTY PULLING IT BACK THROUGH THE CROSS OVER SHEATH. THE DEVICE WAS REMOVED INTACT THROUGH MANIPULATION AND FORCEFUL RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARCATH DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC P56012001 0000507194

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR TERUMO 0.035| CORDIS 8FR CONTRA SHEATH| ABBOT 0.014 GUIDEWIRES