BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYOSPRAY ABLATION SYSTEM

    MDR report key: 1673182 · Received April 29, 2010

    Report

    Report Number
    3004534508-2010-00002
    Event Type
    Death
    Date Received
    April 29, 2010
    Date of Event
    February 24, 2010
    Report Date
    April 21, 2010
    Manufacturer
    CSA MEDICAL INC.
    Product Code
    GEH
    PMA / PMN Number
    K060555
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AUTOPSY REPORT FOR THIS PT CITED THE CAUSE OF DEATH AS ANOXIC ENCEPHALOPATHY, COMPLICATIONS OF ENDOBRONCHIAL BIOPSY AND CRYOABLATION AND METASTATIC RENAL CELL CARCINOMA. THE PHYSICIAN USED THE CRYOSPRAY ABLATION SYSTEM OUTSIDE THE INDICATIONS FOR USE. WHEN INTERVIEWED, THE PHYSICIAN NOTED SHE WAS AWARE THAT BRONCHOSCOPIC USE WAS OUTSIDE OF THE CLEARED INDICATIONS. THE SUCTION SYSTEM, CRYODECOMPRESSION TUBE AND ASSOCIATED VENT TUBING WERE NOT USED DURING TREATMENT. PT WAS VENTILATED VIA ENDOTRACHEAL PRIOR TO CRYOTHERAPY. DURING CRYOTHERAPY, THE VENTILATOR CIRCUIT WAS OPENED TO ENSURE CRYOGENIC GAS COULD VENT ADEQUATELY. PHYSICIAN NOTED THAT THE PT WAS VENTING "EXCELLENTLY" PRIOR TO CHANGES IN ST SEGMENT. IT IS THE PHYSICIAN'S OPINION THAT THE DEVICE WAS NOT RELATED TO THE PT INJURY, ALTHOUGH THE PROCEDURE LIKELY WAS RELATED. A CSA MEDICAL PERSONNEL EVALUATED THE CSA SYSTEM AND FOUND THAT THE EQUIPMENT INVOLVED IN THIS EVENT (NO SUCTION PUMP, NO CDT, NO ACCESSORY TUBING) WAS OPERATING WITHIN SPECIFICATIONS. ALTHOUGH THE EVENT WAS REPORTED TO CHIEF MEDICAL OFFICER (CONSULTANT) FOR CSA MEDICAL AT A CONFERENCE ON FEB. 27, 2010, THAT INFO WAS NOT MADE KNOWN TO CSA QUALITY UNTIL APRIL 1, 2010. THE CONSULTANT AGREEMENT HAS SINCE BEEN TERMINATED.

    Description of Event or Problem · 1

    PT PRESENTED TO SCHEDULED APPOINTMENT WITH SUSPECTED ENDOBRONCHIAL TUMOR RECURRENCE WITH PLEURAL EFFUSION SECONDARY TO METASTATIC RENAL CELL CARCINOMA. PT WAS ANESTHETIZED, INTUBATED, AND VENTILATED. FLEXIBLE BRONCHOSCOPIC EXAMINATION REVEALED A TUMOR OBSTRUCTING A PORTION OF THE BASILAR SEGMENT OF THE LEFT LOWER LOBE. ENDOBRONCHIAL BIOPSY OF TUMOR WAS PERFORMED, AS WELL AS BRUSHINGS AND LAVAGE. CRYOSPRAY ABLATION WAS EMPLOYED AS A MEANS OF PALLIATIVE ENDOBRONCHIAL TUMOR DEBRIDEMENT (TO DESTROY UNWANTED TISSUE AND IMPROVE THE OPENING OF THE AIRWAY). THE VENTILATOR CIRCUIT WAS OPENED TO ENSURE ADEQUATE VENTING OF THE CRYOGENIC GAS. APPROXIMATELY 3 SECONDS INTO CRYOSPRAY, CHANGES IN ST SEGMENT WERE NOTED ON EKG, AND CRYOTHERAPY WAS ABORTED. PT BECAME HYPOTENSIVE, REQUIRING THE ADMINISTRATION OF PRESSORS. THORACENTESIS WAS PERFORMED IN AN EFFORT TO NORMALIZE TRANSIENT DROPS IN O2 LEVEL. THE PT'S STATUS DETERIORATED LATER THAT EVENING AND OVER THE FOLLOWING DAY ((B) (6) 2010). A NEUROLOGY CONSULT YIELDED A POOR PROGNOSIS, AND THE FAMILY OPTED TO EXECUTE A TERMINAL WEAN FROM THE VENTILATOR. PT EXPIRED ON (B) (6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death