BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLAR WAND CRYOTHERAPY SYSTEM (CATHETER SET)

    MDR report key: 1674284 · Received April 29, 2010

    Report

    Report Number
    2529592-2010-00001
    Event Type
    Injury
    Date Received
    April 29, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 26, 2010
    Manufacturer
    GI SUPPLY
    Product Code
    GEH
    PMA / PMN Number
    K041783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POLAR WAND CRYOTHERAPY CATHETER IS A FLEXIBLE TUBE WITH A .030" SINGLE LUMEN. DURING THE MFG PROCESS, A .005" HOLE IS FORMED (NOT BY LASER) AT THE END OF THE CATHETER PRODUCING A HOLE WHICH IS BARELY VISIBLE TO THE NAKED EYE. AFTER THE TIP IS FORMED, EACH CATHETER IS TESTED AND THE FLOW RATE RECORDED. ON APRIL 1, 2010, OUR SALES REP WAS CONTACTED BY THE FACILITY WHERE THE ADVERSE EVENT OCCURRED AND TOLD OF THE EVENT. THE REP WENT TO THE FACILITY THAT DAY AND EXAMINED THE POLAR WAND CATHETER. THE END OF THE POLAR WAND CATHETER HAD BEEN CUT, EXPOSING THE .030" INNER LUMEN. THIS RESULTED IN A SIGNIFICANT INCREASE IN CO2 FLOW RATE. WE HAVE REQUESTED THE CATHETER BE SENT TO THE MFG FACILITY FOR FURTHER EXAMINATION BUT THE DEVICE HAS NOT BEEN RETURNED AS OF THE DATE OF THIS REPORT. AN ADDITION HAS BEEN MADE TO THE POLAR WAND IFU INSTRUCTING THE USER TO VISUALLY INSPECT THE END OF THE CATHETER PRIOR TO USE. IF A LARGE VISIBLE HOLE IS PRESENT, DEVICE IS NOT TO BE USED. A PRECAUTIONARY STATEMENT IS BEING ADDED TO THE IFU WARNING AGAINST ALTERING THE DEVICE IN ANY WAY.

    Description of Event or Problem · 1

    COMPANY REP WAS CONTACTED BY FACILITY TO REPORT ADVERSE EVENT THAT OCCURRED DURING A CRYOTHERAPY PROCEDURE. THE PT WENT INTO RESPIRATORY DISTRESS IMMEDIATELY AFTER THE START OF THE PROCEDURE. THE PT WAS STABILIZED AND TAKEN TO THE OPERATING ROOM FOR EXPLORATORY THORACOTOMY AND LAPAROTOMY WHICH REVEALED A GASTRIC PERFORATION WHICH WAS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR WAND CRYOTHERAPY SYSTEM (CATHETER SET) NONE GEH GI SUPPLY GIS-18 PW0905

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention