BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCONSOLE

    MDR report key: 3857032 · Received June 9, 2014

    Report

    Report Number
    3002648230-2014-00093
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF COMPLAINT INFORMATION, A SERVICE ORDER WAS INITIATED TO REVIEW THE CONSOLE PERFORMANCE ON SITE. CONSOLE PARTS WERE REPLACED AND RETURNED FOR EVALUATION. THE UNIVERSAL PATIENT BOARD AND WATCHDOG BOARD AND PASSED THE INSPECTION AS PER SPECIFICATION. THE AUTO-CONNECTION BOX (PRODUCT # 2037A) WAS ALSO RETURNED FOR EVALUATION AND FAILED THE INSPECTION DUE DAMAGED PIN RECEPTACLES AND IMPEDANCE FLUCTUATION (REFERENCE MFR REPORT: 3002648230-2014-00130). THE REPORTED ISSUE HAS BEEN CONFIRMED THROUGH TESTING AND THROUGH DATA ANALYSIS. THIS FAILURE TYPE SHALL BE MONITORED AND TRENDED AS PART OF MONTHLY RETURN RATE METRICS FOR THE DETERMINATION OF OCCURRENCE LEVEL.

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT NOT MARKETED IN THE US, BUT IS SIMILAR TO UNIVERSAL CRYOCONSOLE MARKETED IN THE US (PMA # P020045). UPON REVIEW OF COMPLAINT INFORMATION, A SERVICE ORDER WAS INITIATED TO REVIEW THE CONSOLE PERFORMANCE ON SITE. CONSOLE PARTS WERE REPLACED AND SUSPECTED DEFECTIVE PARTS OF THE CRYOCONSOLE ARE PENDING RETURN FOR EVALUATION. RESULTS OF EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE USER WAS UNABLE TO BEGIN A CRYOABLATION PROCEDURE DUE TO ISSUES WITH THE CRYOCONSOLE. THE USER EXPERIENCED SYSTEM NOTICE MESSAGES 12218 AND 50006 (REFER TO DESCRIPTIONS BELOW). THE CASE WAS ABORTED; THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR THE PROCEDURE AND DID NOT RECEIVE ANY THERAPEUTIC TREATMENT. SYSTEM NOTICE MESSAGE 12218: THE SAFETY SYSTEM HAS DETECTED A COMPROMISED OUTER VACUUM. SYSTEM NOTICE MESSAGE 50006: THE SAFETY SYSTEM HAS DETECTED BLOOD ON THE CATHETER HANDLE, STOPPED THE INJECTION AND DISABLED THE VACUUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334869 CRYOCONSOLE PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 106E2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other