BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER

    MDR report key: 2993159 · Received March 7, 2013

    Report

    Report Number
    3002648230-2013-00033
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010/S015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED AND PASSED THE INSPECTION AS PER SPECIFICATION. VISUAL INSPECTION SHOWED THE DEVICE WAS INTACT WITH NO APPARENT ISSUES. SMART CHIP VERIFICATION INDICATED THE CATHETER WAS USED FOR 12 INJECTIONS. THE CATHETER PASSED THE PERFORMANCE TEST AND ELECTRICAL INTEGRITY AS PER SPECIFICATION; IMPEDANCE WAS ALSO WITHIN SPECIFICATION. DISSECTION / PRESSURE TESTS DID NOT SHOW ANY LEAKS OR TRACES OF LIQUID/BLOOD INSIDE THE CATHETER. THIS REPORT WILL BE RECORDED AND TRENDED.

    Description of Event or Problem · 1

    A CRYOABLATION PROCEDURE WAS PERFORMED USING A CRYOABLATION CATHETER, A MAPPING CATHETER AND A STEERABLE SHEATH. A TOTAL OF 6 CRYO APPLICATIONS TO THE LSPV AND LIPV COMPLETED SUCCESSFULLY AND THE SHEATH WAS MANIPULATED TO ACCESS THE RIGHT SIDED VEINS. AFTER APPROXIMATELY 13-15 MINUTES OF ATTEMPTS TO ACCESS THE RIPV WITH SHEATH MANIPULATION THE ARTERIAL BP WAS NOTED TO BE DECLINING FROM THE BASELINE OF 110/71 TO 83 SYS. THEN UP TO 90/59, 95/62, 97/61 OVER A 10 MINUTE PERIOD. IT WAS NOTED VIA TTE THAT THE PATIENT HAD DEVELOPED A SMALL PERICARDIAL EFFUSION. IT WAS AT THIS TIME THAT THE PHYSICIAN DISCONTINUED ALL ANTICOAGULATION THERAPY (ACT AT THIS TIME WAS 293), POSITIONED THE BALLOON AND THE SHEATH BACK TO THE RIGHT SIDE FROM THE LA AND ADMINISTERED 60 MG OF PROTAMINE FOR REVERSAL OF THE HEPARIN ADMINISTERED DURING THE PROCEDURE. PATIENT LEFT THE EP LAB IN STABLE CONDITION, ALERT AND ORIENTED WITH VITAL SIGNS WITHIN NORMAL LIMITS. DEVICE 1 OF 3, REFERENCE MFR REPORTS: 3002648230-2013-00034 AND 3007798852-2013-00004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98201 ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION OAE MEDTRONIC CRYOCATH LP 2AF284

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Other ACHIEVE MAPPING 990063-020, FLEXCATH SHEATH 3FC12