BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOCONSOLE

    MDR report key: 6622937 · Received June 8, 2017

    Report

    Report Number
    3002648230-2017-00265
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    May 16, 2017
    Report Date
    July 5, 2017
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    UDI-DI
    00643169279063
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE PATIENT DATA FILES DID SHOW THAT DURING MULTIPLE INJECTIONS THERE WAS OSCILLATION WITHIN THE FLOW AND TEMPERATURE PERFORMANCE. THE FILES ALSO DID SHOW THE SYSTEM NOTICE (#50030) INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION AT APPLICATIONS TWO, THREE AND FOUR WITH CATHETER 2AF284/79918-40 WHICH WAS USED FOR SEVEN INJECTIONS. CONSOLE 106A3/ N6847 WAS SERVICED. THE REPORTED ISSUE DOES NOT INDICATE A CONSOLE MANUFACTURING RELATED DEFECT. DURING SERVICE AND REPAIR ON THE CONSOLE, THE TANK NUT AND THE NIPPLE FILTER WERE FOUND TO BE DIFFERENT FROM THE NORMAL ONES. THE NIPPLE FILTER AND TANK NUT WERE REPLACED. THE WATCH BOARD WAS ALSO REPLACED. IN CONCLUSION, THE REPORTED ISSUES (SYSTEM NOTICE #50030, TEMPERATURE, FLOW) WERE NOT CONFIRMED THROUGH TESTING BUT DATA ANALYSIS. THE REPORTED ISSUE (SYSTEM NOTICE #50017) INDICATING THAT THE OPERATIONAL TEMPERATURE OF THE SYSTEM WAS HIGH, PREVENTING PROPER OPERATION HAS NOT BEEN CONFIRMED THROUGH THE TESTING AND DATA ANALYSIS. THE CONSOLE FAILED THE INSPECTION BY FIELD SERVICE ENGINEER DUE TO DEFECTIVE NIPPLE FILTER, TANK NUT AND WATCH DOG BOARD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, SYSTEM NOTICES WERE RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED A HIGH LEVEL OF REFRIGERANT FLOW AND STOPPED THE INJECTION. ADDITIONALLY, TEMPERATURE ISSUES WERE OBSERVED. THE COAXIAL UMBILICAL CABLE WAS EXCHANGED TWICE WITH NO RESOLVE. IT WAS ALSO NOTED THAT FLOW AND PRESSURE WERE FLUCTUATING. THE ELECTROPHYSIOLOGY (EP) CATHETER WAS THEN REPLACED WITHOUT RESOLVE. ADDITIONALLY, THE REFRIGERANT TANK WAS CLOSED AND REOPENED, HOWEVER, TEMPERATURES WERE STILL NOT DROPPING DESPITE TARGET FLOW RANGE BEING MET. THE TANK WAS THEN REPLACED WITHOUT RESOLVE. ALSO, THE PHYSICIAN WAS ABLE TO OBTAIN GOOD TEMPERATURES WHEN ABLATING IN A SALINE BATH WITH THE SAME CONSUMABLES. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. TEST INJECTIONS WERE PERFORMED ON THE CONSOLE AND A SYSTEM NOTICE WAS RECEIVED MULTIPLE TIMES INDICATING THAT THE OPERATIONAL TEMPERATURE OF THE SYSTEM WAS HIGH, PREVENTING PROPER OPERATION. A FIELD SERVICE VISIT WAS SCHEDULED FOR A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402860 CRYOCONSOLE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 106A3 00643169279063

    Patients

    Seq Age Sex Outcome Treatment
    1 Other