BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GI SUPPLY POLAR WAND CRYOTHERAPY SYSTEM

    MDR report key: 4142533 · Received October 1, 2014

    Report

    Report Number
    2529592-2014-00001
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 25, 2014
    Manufacturer
    GI SUPPLY, INC.
    Product Code
    GEH
    PMA / PMN Number
    K041783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COORDINATING RETURN OF MACHINE FOR INSPECTION/EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, MANUFACTURER WAS NOTIFIED BY USER FACILITY THAT TREATING PHYSICIAN WAS USING GI SUPPLY GIS -19 POLAR WAND CRYOTHERAPY SYSTEM ("POLAR WAND SYSTEM") ON A PROCEDURE WITH PATIENT WHEN THE PATIENT EXPERIENCED A PERFORATION OF THE CARDIA BELOW THE GASTROESOPHAGEAL JUNCTION. THE AREA OF PERFORATION WAS ENDOSCOPICALLY CLIPPED TO SUCCESSFULLY CLOSE THE PERFORATION, AND THE PATIENT WAS ADMITTED INTO THE HOSPITAL WHERE THE TREATMENT WAS BEING PERFORMED AND CONDITION WAS IMPROVING. UPON REVIEW OF THE EVENT WITH USER FACILITY NURSE AND RISK MANAGER, IT WAS DISCLOSED THAT THE PATIENT HAD A HISTORY OF BARRETT'S ESOPHAGUS AND PREVIOUS RF ABLATION TREATMENT (UNRELATED TO THE POLAR WAND SYSTEM) WHICH RESULTED IN A SCARRED/NARROW ESOPHAGUS WITH STRICTURES. THE TREATING PHYSICIAN CHOSE TO USE THE POLAR WAND SYSTEM WITHOUT THE USE OF THE GI SUPPLY EVACUATION TUBING ("SUCTION") CAP INSTALLED ON THE TIP OF THE CRYOTHERAPY CATHETER; THE EVACUATION TUBING IS SUPPLIED BY GI SUPPLY WITH THE CRYOTHERAPY CATHETER KIT. THE TREATING PHYSICIAN UTILIZED ENDOSCOPE SUCTION, PLACED IN THE STOMACH, INTERMITTENTLY BETWEEN CRYOTHERAPY CATHETER SPRAYS. THE USER FACILITY RISK MANAGER STATED THAT THE GI SUPPLY CRYOTHERAPY SYSTEM DID NOT MALFUNCTION AT ANY TIME DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611577 GI SUPPLY POLAR WAND CRYOTHERAPY SYSTEM CRYOSURGICAL SYSTEM GEH GI SUPPLY, INC. GIS-19

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R