BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2043179 · Received February 24, 2011

    Report

    Report Number
    3002648230-2011-00006
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 26, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP.
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND INVESTIGATED AS FOLLOWS: BIN FILES ANALYSIS SHOWED SYSTEM NOTICE ERROR 50006 (AS REPORTED) AND ALSO SHOWED SYSTEM NOTICE ERROR 50005 (THE SAFETY SYSTEM HAS DETECTED FLUID IN THE CATHETER AND STOPPED THE INJECTION). VISUAL INSPECTION SHOWED THE PRESENCE OF BLOOD IN THE CATHETER. PRESSURE TEST REVEALED A LEAK THROUGH THE GUIDE WIRE LUMEN, HOWEVER, THE BALLOON INTEGRITY WAS INTACT WITH NO BREACH. DISSECTION SHOWED A GUIDE WIRE LUMEN PARTIAL SNAPPING AT THE COIL. A CORRECTIVE ACTION WAS INITIATED TO ADDRESS THIS ISSUE. THE DEVICE INVOLVED IN THIS EVENT IS SIMILAR TO THE ARCTIC FRONT CARDIAC CRYOABLATION CATHETER MARKETED IN THE US.

    Description of Event or Problem · 1

    DURING CRYOABLATION PROCEDURE USING THE ARCTIC FRONT CATHETER, THE CRYO-CONSOLE SHOWED SYSTEM NOTICE ERROR 50006 (THE SAFETY SYSTEM HAD DETECTED BLOOD ON THE CATHETER HANDLE, STOPPED THE INJECTION AND DISABLED THE VACUUM). THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER CARDIOVASCULAR CATHETER OAE MEDTRONIC CRYOCATH LP. 2AF231 79221-20

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN