BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOCONSOLE

    MDR report key: 6072603 · Received November 2, 2016

    Report

    Report Number
    3002648230-2016-00471
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DATA FILES FOR THE DATE OF THE REPORTED EVENT AND FIELD SERVICE ENGINEERING REPORT (FSER) WERE RETURNED AND ANALYZED. THE DATA FILES DID NOT SHOW ANY INJECTIONS OR SYSTEM NOTICES. AS PER THE FSER, THE HIGH BASELINE FLOW COULD NOT BE REPRODUCED AS IT WAS WITHIN NORMAL RANGE UPON ARRIVAL FOR SERVICE. IT WAS NOTED THAT BASELINE FLOW IS KNOWN TO BE AN INTERMITTENT ISSUE AND THE CHECK VALVE FOUR (CV4) WAS REPLACED. THE CONSOLE PASSED ALL INSPECTION AND TESTS AND WAS DEEMED APPROPRIATE FOR USE. THE PRODUCT ISSUE REPORTED (HIGH BASELINE FLOW) 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.

    Additional Manufacturer Narrative · 1

    CORRECTION.

    Additional Manufacturer Narrative · 1

    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 BASELINE FLOW ICON HAD APPEARED ON THE CONSOLE MONITOR SCREEN. THE CATHETER AND COAXIAL CABLE WERE REPLACED, AND THE CONSOLE WAS REBOOTED WITHOUT RESOLVE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. A FIELD SERVICE VISIT TOOK PLACE ON A LATER DATE IN WHICH THE CONSOLE WAS SERVICED AS APPROPRIATE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, A BASELINE FLOW ICON HAD APPEARED ON THE CONSOLE MONITOR SCREEN. THE CATHETER AND COAXIAL CABLE WERE REPLACED, AND THE CONSOLE WAS REBOOTED WITHOUT RESOLVE. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723246 CRYOCONSOLE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 106A3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other