BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOCONSOLE

    MDR report key: 8760423 · Received July 3, 2019

    Report

    Report Number
    3002648230-2019-00474
    Event Type
    Injury
    Date Received
    July 3, 2019
    Date of Event
    June 7, 2019
    Report Date
    July 3, 2019
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    UDI-DI
    00643169449596
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DATA FILES WERE RETURNED AND ANALYZED. THE DATA FILES INDICATED THE ELECTROPHYSIOLOGY (EP) CATHETER 227F3 WITH LOT NUMBER 872218 WAS USED FOR ONE APPLICATION AND SYSTEM NOTICE 50005, INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION, WAS RECEIVED. IN CONCLUSION, THE REPORTED SYSTEM NOTICE 50005, INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION, IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY; HOWEVER, THE RISK OF THE PATIENT BEING UNDER GENERAL ANESTHESIA WITHOUT FULL THERAPEUTIC EFFECT IS THE ADVERSE EVENT BEING REPORTED. THE DECISION TO ABORT THE PROCEDURE WITHOUT USE OF ALTERNATE THERAPY WAS BASED UPON THE MEDICAL JUDGMENT OF THE PHYSICIAN. 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, A SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE COAXIAL UMBILICAL CABLE, ELECTRICAL UMBILICAL CABLE AND ELECTROPHYSIOLOGY (EP) CATHETER WERE REPLACED, AND THE CONSOLE WAS REBOOTED, WITHOUT RESOLVE. ANOTHER SYSTEM NOTICE WAS RECEIVED INDICATING THAT THE SAFETY SYSTEM DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION. THE SAME PRODUCTS WERE REPLACED WITHOUT RESOLVE. THE CASE WAS ABORTED WITH THE PATIENT UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554058 CRYOCONSOLE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 106A3 00643169449596

    Patients

    Seq Age Sex Outcome Treatment
    1 Other