BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLAR WAND CRYOTHERAPY SYSTEM

    MDR report key: 1194438 · Received October 9, 2008

    Report

    Report Number
    2529592-2008-00003
    Event Type
    Injury
    Date Received
    October 9, 2008
    Date of Event
    September 11, 2008
    Report Date
    October 8, 2008
    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

    Description of Event or Problem · 1

    PATIENT DEVELOPED A PNEUMOPERITONEUM DURING CRYOTHERAPY TREATMENT FOR GASTRIC ANTRAL VASCULAR ECTASIA (GAVE). A GASTROGRAFFIN SWALLOW WAS NEGATIVE FOR PERFORATION. AFTER A LENGTHY DISCUSSION WITH A SURGEON, THE PATIENT REQUESTED SURGICAL RESECTION AND UNDERWENT A SUBTOTAL GASTRECTOMY FOR TREATMENT OF THE GAVE. DURING SURGERY, NO GROSS CONTAMINATION OR INJURY TO THE GASTRIC WALL WAS IDENTIFIED. AFTER THE SURGEON ACHIEVED SIGNIFICANT DISTENSION VIA AN ENDOSCOPE, AN AREA OF PERFORATION HIGH ON THE LESSER CURVE OF THE STOMACH WAS IDENTIFIED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAS RECOVERED. THERE WAS NO DEVICE MALFUNCTION DURING THE ABLATION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR WAND CRYOTHERAPY SYSTEM CRYOSURGICAL UNIT AND ACCESSORIES GEH GI SUPPLY GIS-19

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R