BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARCATH

    MDR report key: 1172510 · Received September 19, 2008

    Report

    Report Number
    2134265-2008-02747
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 29, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K022061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: PRODUCT ANALYSIS CONFIRMED THE DIFFICULTY STATED IN THE COMPLAINT. DURING FUNCTIONAL TESTING, TREATMENT ABORTED DURING SELF TEST, ENDING WITH A FLASHING CHECK VAC LIGHT. DOWNLOAD RECORDS A VACUUM PRESSURE ERROR, AND LEAK TEST SHOWED LEAK IN THE OUTER BALLOON. VISUAL INSPECTION FOUND TRACES OF BLOOD FOUND IN THE BALLOON AREA. USING A MICROSCOPE FOUND A RIP IN THE OUTER BALLOON RUNNING 2.6CM LONG FROM THE PROXIMAL END OF THE BALLOON TOWARD THE MIDDLE. SCORING MARKS ON THE BALLOON CONTINUES FROM THE RIPPED AREA TOWARD THE DISTAL END. A REVIEW OF THE MANUFACTURING RECORD FOR THIS PARTICULAR BATCH SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS DETERMINED TO BE OPERATIONAL CONTEXT DUE TO THE ANATOMICAL AND/OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    THIS EVENT IS REPORTABLE BASED ON THE PRODUCT ANALYSIS APPROVED ON 09/18/2008. IT WAS REPORTED THAT DURING A CRYOPLASTY PROCEDURE, THE CHECK CATHETER LIGHT CAME ON. THE LESION WAS LOCATED IN THE POPLITEAL ARTERY. THE PHYSICIAN ADVANCED THE .035-3X100 POLARCATH BALLOON CATHETER TO THE LESION AND DURING THE TREATMENT CYCLE THE CHECK CATHETER LIGHT CAME ON. WHEN THE LIGHT CAME ON, THE SYSTEM EXHAUSTED ALL THE GAS AND DID NOT WORK PROPERLY. THERE WERE NO PT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER .035-3X100 POLARCATH BALLOON CATHETER. HOWEVER, THE RETURNED PRODUCT ANALYSIS REVEALED THAT THERE WAS A BALLOON TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARCATH DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC M001T30100150010 11608835

    Patients

    Seq Age Sex Outcome Treatment
    1