BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCTIC FRONT CARDIAC CRYOABLATION CATHETER

    MDR report key: 2010583 · Received March 1, 2011

    Report

    Report Number
    3002648230-2011-00010
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 31, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MEDTRONIC CRYOCATH LP
    Product Code
    OAE
    PMA / PMN Number
    P100010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED CATHETER WAS VISUALLY AND FUNCTIONALLY TESTED AND PASSED THE INSPECTION AS PER SPECIFICATIONS.

    Description of Event or Problem · 1

    A CRYOABLATION PROCEDURE WAS PERFORMED USING THE ARCTIC FRONT CATHETER. A PHRENIC NERVE INJURY OCCURRED AT APPROXIMATELY 1 MINUTE INTO THE FIRST ABLATION IN THE RIGHT SUPERIOR PULMONARY VEIN OSTIUM. THE DOCTOR WAS PACING THE PHRENIC NERVE AT 2000 MS. ABLATION WAS STOPPED IMMEDIATELY UPON LOSS OF PHRENIC NERVE CAPTURE. PHRENIC NERVE FUNCTION DID NOT RECOVER AT THE END OF THE PROCEDURE. THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011 AND APPEARED TO BE ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCTIC FRONT CARDIAC CRYOABLATION CATHETER CARDIOVASCULAR CATHETER OAE MEDTRONIC CRYOCATH LP 2AF282 07293

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability