BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 1069515 · Received May 7, 2008

    Report

    Report Number
    127116-2008-00005
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    April 7, 2008
    Report Date
    May 7, 2008
    Manufacturer
    CSA MEDICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    k060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRIOR TO THERAPY, THE PHYSICIAN PLACED AN INK TATTOO IN THE ESOPHAGEAL WALL USING A SCLERA THERAPY NEEDLE NEAR THE TREATMENT SITE. IT IS THE OPINION OF THE TREATING PHYSICIAN THAT NITROGEN GAS INFILTRATED THE ESOPHAGEAL WALL THROUGH THE NEEDLE PUNCTURE SITE INTRODUCED DURING THE TATTOO PROCESS. INVESTIGATION BY CSA MEDICAL CONCLUDED THAT THIS WAS THE MOST LIKELY CAUSE OF THE MICRO-PERFORATION. TATTOOING IS A PROCEDURE USED TO MARK TREATMENT OR DISEASE SITES, OFTEN DURING CLINICAL RESEARCH. THE PROCESS CAN COMPROMISE THE INTEGRITY OF THE GASTROINTESTINAL TRACT AND SHOULD NOT BE DONE PRIOR TO THERAPY. THIS WAS CLARIFIED WITH THE TREATING PHYSICIAN.

    Description of Event or Problem · 1

    A PT DEVELOPED AN ESOPHAGEAL MICROPERFORATION WITH PNEUMOMEDIASTINUM AND SUBCUTANEOUS EMPHYESMA (AIR) IMMEDIATELY AFTER TREATMENT WITH THE CSA CRYOSPRAY. A GASTROGRAFFIN SWALLOW WAS NEGATIVE FOR A PERFORATION (I.E. SHOWED NO LEAK.) THE PT WAS HOSPITALIZED AND MANAGED WITH IV ANTIBIOTICS. THE CONDITION RESOLVED COMPLETELY AND THE PT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYOSPRAY ABLATION SYSTEM CRYOSPRAY GEH CSA MEDICAL, INC. CC2-NAM *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization