BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARCATH

    MDR report key: 1111883 · Received August 12, 2008

    Report

    Report Number
    2134265-2008-02298
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 22, 2008
    Report Date
    July 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K022061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYOPLASTY PROCEDURE, THE BALLOON FAILED TO DEFLATE. THE 60% STENOTIC LESION WAS LOCATED AT THE TAKE OFF FOR THE PROFUNDA IN THE NON-TORTUOUS AND MODERATELY CALCIFIED COMMON FEMORAL ARTERY. THE PHYSICIAN ADVANCED THE .014-4X60MM POLARCATH BALLOON CATHETER TO THE LESION AND SUCCESSFULLY COMPLETED THE FIRST INFLATION TREATMENT PHASE. WHEN THE SYSTEM RELEASED THE GAS, THE BALLOON FAILED TO DEFLATE. THE PHYSICIAN ATTEMPTED TO USE A SYRINGE TO PULL A NEGATIVE PRESSURE, BUT FAILED. THE PHYSICIAN THEN OBSERVED THAT THE HUB WAS CRACKED. THE PHYSICIAN THEN COVERED THE HUB WITH DURABOND AND WAS THEN ABLE TO PULL A NEGATIVE PRESSURE AND DEFLATE AND REMOVE THE BALLOON. FIXING THE HUB TOOK ABOUT TEN MINUTES. THERE WERE NO PATIENT COMPLICATIONS. THE PROCEDURE WAS COMPLETED WITH A REGULAR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND THE DEPLOYMENT OF A STENT. PATIENT STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARCATH DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC M001T4060150010 11732472

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CORDIS CONTRA 6 FR SHEATH| MIRACLE BROS. 3 014" GUIDEWIRE