BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 1101723 · Received August 7, 2008

    Report

    Report Number
    3004534508-2008-00007
    Event Type
    Injury
    Date Received
    August 7, 2008
    Date of Event
    July 7, 2008
    Report Date
    August 7, 2008
    Manufacturer
    CSA MEDICAL, INC
    Product Code
    NEJ
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TREATING PHYSICIAN REPORTED THAT THE CRYO-DECOMPRESSION TUBE ("CDT") WAS NOT USED DURING THE THREE COMPLETED TREATMENT CYCLES. THE CDT IS DESIGNED TO VENT LN2 GAS DURING THE PROCEDURE. BEFORE STARTING THE FOURTH AND FINAL TREATMENT SPRAY, THE PHYSICIAN INSERTED THE CDT TO ASSIST IN DECOMPRESSION FROM THE GAS. DUE TO THE PATIENT'S COMPLAINTS OF DISCOMFORT, THE FOURTH AND FINAL SPRAY WAS NOT INITIATED. THE PT DRESSED AND STATED HE FELT BETTER. PT LEFT AND THREE HOURS LATER, WENT TO THE ER COMPLAINING OF LOWER ABDOMINAL PAIN AND CRAMPING. CT SCAN WAS DONE AND SHOWED AIR OUTSIDE THE BOWEL IN THE AREA OF THE CECUM. THE PT WAS TAKEN TO SURGERY AND A PORTION OF HIS COLON NEAR THE CECUM WAS REMOVED. THE REMOVED AREA WAS SENT TO PATHOLOGY AND THE RESULTS OF THE HISTOLOGICAL EXAMINATION REVEALED NO PERFORATION. IT IS SUSPECTED THAT A MICRO-PERFORATION MAY HAVE BEEN PRESENT AND HEALED ITSELF IN THE HOURS BETWEEN THE EVENT AND THE SURGERY. PHYSICIAN INDICATED THAT THIS WAS POSSIBLE. CSA MEDICAL CONSULTED A MEDICAL EXPERT WHO SUGGESTED PRE-EXISTING CONDITIONS, SUCH AS A HERNIA OR ABNORMAL FISTULA, MAY HAVE CONTRIBUTED TO THE EVENT. THIS COULD NOT BE CONFIRMED. IT IS KNOWN THAT THE TREATING PHYSICIAN DID NOT PLACE THE DECOMPRESSION TUBE PRIOR TO CRYO-THERAPY, WHICH IS CONTRARY TO TRAINING AND LABELING.

    Description of Event or Problem · 1

    A PT RECENTLY TREATED WITH THE CRYOSPRAY ABLATION SYSTEM FOR RADIATION PROCTITIS COMPLAINED OF ABDOMINAL DISCOMFORT. PT RETURNED TO THE HOSPITAL WHERE TESTING REVEALED AIR IN THE CECAL CAVITY. AN OBVIOUS PERFORATION WAS NOT IDENTIFIED, ALTHOUGH THE AREA WAS INFLAMED. SURGERY WAS PERFORMED TO REMOVE AN AREA OF THE CECUM AS THE PHYSICIAN SUSPECTED A PERFORATION. THE PT WAS HOSPITALIZED FOR FOUR DAYS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention