BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 2190140 · Received October 26, 2007

    Report

    Report Number
    3004534508-2007-00003
    Event Type
    Injury
    Date Received
    October 26, 2007
    Date of Event
    September 28, 2007
    Report Date
    October 26, 2007
    Manufacturer
    CSA MEDICAL
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN STATED THAT HE BELIEVED THE (B)(4) TEAR OCCURRED AS A RESULT OF THE FORCEFUL COUGHING. AS DOCUMENTED IN MEDICAL LITERATURE, THIS IS A COMMON CAUSE OF A (B)(4) TEAR. THE PATIENT HAS A KNOWN HISTORY OF COPD AND CHF. IT IS NOT KNOWN TO WHAT EXTENT THIS MAY HAVE CONTRIBUTED TO THE PATIENT'S PULMONARY DISTRESS AND POOR OXYGENATION (HYPOXIA). MULTIPLE ATTEMPTS BY CSA MEDICAL PERSONNEL TO OBTAIN A DETAILED PATIENT HISTORY, CURRENT PHYSICAL CONDITION, MEDICATION LIST AND A DOCUMENTED DIAGNOSIS FROM THE PHYSICIAN HAVE BEEN UNSUCCESSFUL. TWO CSA MEDICAL CLINICAL SPECIALISTS WERE ON-SITE OBSERVING THE PROCEDURE AT THE TIME OF THE EVENT. IT WAS NOTED THAT THE CRYOSPRAY ABLATION SYSTEM APPEARED TO BE FUNCTIONING PROPERLY AND WAS BEING USED BY A PHYSICIAN IN A MANNER CONSISTENT WITH CSA TRAINING AND INSTRUCTIONS FOR USE. FOLLOWING THE EVENT, THE PHYSICIAN PERFORMED SEVERAL OTHER PROCEDURES USING CRYOSPRAY ABLATION SYSTEM S/N (B)(4). ALL WERE SUCCESSFULLY COMPLETED WITH NO REPORTED PROBLEMS. ON (B)(6) 2007, CSA MEDICAL EVALUATED THE CRYOSPRAY ABLATION UNIT AT THE HOSPITAL AND CONFIRMED THAT IT MET ALL SPECIFICATIONS. A REVIEW OF PRODUCTION RECORDS SHOW THAT CATHETER KITS FROM LOT 9978 ALSO MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A PROCEDURE USING THE CRYOSPRAY ABLATION SYSTEM, THE PATIENT EXPERIENCED A MALLORY-WEISS TEAR IN THE ESOPHAGUS. THE PATIENT ALSO EXHIBITED PULMONARY DISTRESS. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. THE PATIENT BEGAN FORCEFULLY COUGHING AND HEAVING DURING THE SECOND CRYO THERAPY TREATMENT. THE PHYSICIAN SUBSEQUENTLY STOPPED THE PROCEDURE; ADDITIONAL SEDATION (ANESTHESIA) WAS ADMINISTERED TO CALM THE PATIENT. UPON RE-INSERTING THE ENDOSCOPE TO RE-START TREATMENT, A (B)(4) TEAR WAS NOTED DISTALLY FROM THE CRYO TREATMENT SITES. THE PROCEDURE WAS AGAIN STOPPED. ONCE THE ENDOSCOPE WAS REMOVED FROM THE PATIENT, THE PATIENT'S OXYGEN LEVEL FELL VERY LOW. THE PATIENT WAS GIVEN SUPPLEMENTAL OXYGEN TO BRING UP THE SATURATION LEVELS. PATIENT WENT TO RECOVERY ROOM STILL IN PULMONARY DISTRESS, AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT REMAINED HOSPITALIZED THREE DAYS POST PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization