BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYOCONSOLE

    MDR report key: 4180438 · Received October 17, 2014

    Report

    Report Number
    3002648230-2014-00169
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    LPB
    PMA / PMN Number
    P020045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONSOLE PERFORMANCE WAS EVALUATED ON SITE BY FIELD SERVICE ENGINEERING AND THE REPORTED ISSUES COULD NOT BE REPRODUCED. MEDICAL EQUIPMENT INSPECTION AND ELECTRICAL SAFETY TEST WERE PERFORMED ON THE CONSOLE. PATIENT CABLE AND PATIENT BOARD WERE REPLACED DURING CONSOLE MAINTENANCE. BIN FILES WERE REVIEWED AND CONFIRMED THE SYSTEM NOTICE MESSAGE 50006 ¿BLOOD DETECTION¿ FOR THE DATE OF EVENT. THE TWO ARCTIC FRONT ADVANCE CATHETERS USED DURING THE CASE WERE RETURNED FOR INVESTIGATION. THE FIRST CATHETER USED DURING THE CASE FAILED THE RETURNED PRODUCT INSPECTION DUE TO A DEFECTIVE BLOOD DETECTION BOARD WHICH RESULTED IN SYSTEM NOTICE MESSAGE 50006. BOTH CATHETERS FAILED THE RETURNED PRODUCT INSPECTION DUE TO A BENT ELECTRICAL PIN WHICH EXPLAINS "CATHETER NOT RECOGNIZED" SYSTEM NOTICE MESSAGE. INSPECTION OF THE RETURNED CATHETERS SUGGESTS A USER ERROR CONTRIBUTED TO THE EVENT; WHEN ATTEMPTING TO CONNECT THE CATHETERS, THE USER WAS NOT PROPERLY ALIGNING THE CATHETER THEREBY CAUSING THE PIN TO BEND. THIS REPORT WILL BE RECORDED AND TRENDED.

    Additional Manufacturer Narrative · 1

    BIN FILES WERE REVIEWED AND CONFIRMED THE SYSTEM NOTICE MESSAGE 50006 ¿BLOOD DETECTION¿ FOR THE DATE OF EVENT. UPON REVIEW OF COMPLAINT INFORMATION, A SERVICE ORDER WAS INITIATED TO REVIEW THE CONSOLE PERFORMANCE ON SITE. CONSOLE PARTS WERE REPLACED AND WILL RETURNED FOR EVALUATION. RESULTS OF INVESTIGATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (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

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE USER WAS UNABLE TO BEGIN A CRYOABLATION PROCEDURE DUE TO ISSUES WITH THE CONSOLE. THE USER EXPERIENCED SYSTEM NOTICE MESSAGES 50006 (THE SAFETY SYSTEM HAS DETECTED BLOOD ON THE CATHETER HANDLE, STOPPED THE INJECTION AND DISABLED THE VACUUM) AND 12215 (THE SYSTEM DOES NOT RECOGNIZE THE CATHETER). THE CONSOLE THEN MADE A LOUD CLICKING NOISE WHICH STOPPED WHEN THE CATHETER WAS DISCONNECTED FROM THE CONSOLE. CABLES, AUTOCONNECTION BOX AND CATHETER WERE ALL REPLACED WITHOUT RESOLVE. THE CASE WAS ABORTED; THE PATIENT WAS UNDER GENERAL ANESTHESIA FOR THE PROCEDURE AND DID NOT RECEIVE ANY THERAPEUTIC TREATMENT. AT NO TIME WAS THE CATHETER PLACED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663099 CRYOCONSOLE CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC CRYOCATH LP 106E2

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Other