BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYOCONSOLE

    MDR report key: 5245884 · Received November 24, 2015

    Report

    Report Number
    3002648230-2015-00416
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    November 16, 2015
    Report Date
    August 4, 2016
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT SUMMARY: THE BIN FILES ATTACHED TO SERVICEMAX RECORDS DID NOT SHOW ANY BIN FILE FOR THE DATE OF EVENT. FOR THE UNIVERSAL PATIENT BOARD 11000-S129-01/1294810078, UPON VISUAL INSPECTION RESULTS SHOWED THAT THE BOARD WAS INTACT WITH NO APPARENT ISSUES. THE BOARD WAS ASSEMBLED TO GEN V CONSOLE AS PER FSM INSTRUCTIONS. THE CONSOLE FAILED THE POWER UP TEST DUE TO A POWER UP ERROR (ERROR1 = 0-0-1C000000, ERROR2 = 0-0-0). DESCRIPTION OF THESE CODES IS THAT THE TEMPERATURE REFERENCE 40, TEMPERATURE REFERENCE 0 AND TEMPERATURE REFERENCE -80 ARE OUT OF SPECIFICATION SIMULTANEOUSLY (TMT). THE BOARD WAS RE-CALIBRATED AS PER FSM INSTRUCTIONS. REBOOT OF THE CONSOLE DID NOT TRIGGER ANY POWER UP TEST ERROR. THE CONSOLE ALONG WITH BALLOON TEST CATHETER PASSED THE PERFORMANCE TEST. THE INFLATION WAS SUSTAINED FOR PLUS 120 SECONDS. FOR THE WATCHDOG BOARD M731190B001/1424810043, UPON VISUAL INSPECTION RESULTS SHOWED THAT THE BOARD WAS INTACT WITH NO APPARENT ISSUES. THE BOARD WAS ASSEMBLED TO GEN V CONSOLE AS PER FSM INSTRUCTIONS. THE CONSOLE FAILED THE POWER UP TEST DUE TO ERROR1 = 0-2000000-0, ERROR2 = 0-0-0 (SYSTEM NOTICE 11200). DESCRIPTION OF THESE CODES IS THAT TEST TO VERIFY THE OPERATION OF THE WATCHDOG BOARD WATCHDOG TIMER FAILED. THE CONSOLE WAS REBOOTED AND THE CONSOLE PASSED THE POWER UP TEST. THE CONSOLE ALONG WITH THE RETURNED PATIENT BOARD AND BALLOON TEST CATHETER PASSED THE PERFORMANCE TEST. MULTIPLE APPLICATIONS WERE PERFORMED WITHOUT ANY ISSUE. THE INFLATION WAS SUSTAINED FOR PLUS 120 SECONDS. FOR THE CONSOLE N-6271, THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION; STILL IN USE. TECHNICAL SUPPORT WAS NOTIFIED OF THIS OC CURRENCE. UPON REVIEW OF COMPLAINT INFORMATION, A WORK ORDER WAS INITIATED TO REVIEW CONSOLE PERFORMANCE ON SITE. IN CONCLUSION: THE REPORTED ISSUE HAS NOT BEEN CONFIRMED THROUGH TESTING AND THROUGH DATA ANALYSIS. THE UNIVERSAL PATIENT BOARD 1100 0-S129-01/1294810078 FAILED THE INSPECTION DUE TO TEMPERATURE REFERENCE OUT OF SPECIFICATION. THE WATCHDOG BOARD M731190B001/1424810043 FAILED THE POWER UP TEST DUE TO SYSTEM NOTICE 11200. THE TEST IS RELATED TO A TEST THAT VERIFIES THE OPERATION OF THE WATCHDOG BOARD TIMER. THE WATCHDOG BOARD WATCHDOG TIMER TEST MIGHT BE MARGINAL. FOR THE CONSOLE, REPLACEMENT OF THE WATCHDOG AND PATIENT BOARD S RESOLVED THE ISSUE. THIS REPORT IS SUBMITTED DUE TO THE ADVERSE EVENT OF THE PROCEDURE BEING ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    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 CRYOABLATION PROCEDURE, THE CRYOCONSOLE WAS NOT RESPONDING TO THE GREEN INFLATE BUTTON. THE COAXIAL CABLE WAS DISCONNECTED AND RECONNECTED WITHOUT RESOLVE. THEN, THE COAXIAL CABLE WAS REPLACED, THE CONSOLE WAS REBOOTED, AND THE FOOT SWITCH WAS CONNECTED, ALL WITHOUT RESOLVE. FIELD SERVICE WAS RECOMMENDED, AND THE CONSOLE HAS SINCE BEEN SERVICED. THE CASE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA; HOWEVER, NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775559 CRYOCONSOLE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 106A3

    Patients

    Seq Age Sex Outcome Treatment
    1 Other