BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEZOR MAX SURGICAL

    MDR report key: 731216 · Received June 30, 2006

    Report

    Report Number
    3002648230-2006-00005
    Event Type
    Injury
    Date Received
    June 30, 2006
    Date of Event
    June 2, 2006
    Report Date
    June 30, 2006
    Manufacturer
    CRYOCATH TECHNOLOGIES, INC.
    Product Code
    NFC
    PMA / PMN Number
    P-020045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FIFTY ONE YEAR OLD MAY WITH WPW SYNDROME. (RIGHT POSTEROSEPTAL ACCESSORY PATHWAY AND SVT). WHO UNDERWENT APPARENTLY SUCCESSFUL RF ABLATION 6/1/06. HE HAD RECURRENT SVT IN HOSP AFTER ABLATION AND RETURNED TO EP LAB FOR A SECOND PROCEDURE. THIS REVEALED A CONCEALED RIGHT POSTEROSEPTAL ACCESSSORY PATHWAY ( NO PRE-EXCITATION IN SINUS RHYTHM). A FREEZORTM 4MM F1 CURVE CATHETER WAS UNABLE TO REACH THE TARGET ABLATION SITE. AN FREEZOR MAX 8MM(F5) CRYOBLATION CATHETER WAS SUCCESSFULLY POSITIONED AT TARGET ABLATION SITE. SEVERAL CRYOBLATIONS IN THIS REGION, EACH LASTING 15 SECONDS, HAD NO EFFECT ON RETROGRADE ACCESSORY PATHWAY CONDUCTION, AS ASSESSED DURING RIGHT VENTRICULAR PACING. ANOTHER CRYOBLATION WAS MADE, BUT WAS CONTINUED FOR 50 SECONDS DUE TO MISCOMMUNICATION BETWEEN THE OPERATORS IN THE LABORATORY. VENTRICULAR PACING WAS CARRIED OUT DURING THIS ABLATION, WITH NO EFFECT SEEN ON RETROGRADE ACCESSORY PATHWAY CONDUCTION. WHEN THE ABLATION AND VENTRICULAR PACING WERE DISCONTINUED COMPLETE AV BLOCK WAS NOTED. THIS PERSISTED FOR THE NEXT SEVERAL DAYS, AFTER WHICH A PERMANENT PACEMAKER WAS IMPLANTED. SEVERAL WEEKS LATER AV CONDUCTION WAS NOTED TO HAVE REAPPEARED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR MAX SURGICAL FREEZOR MAX SURGICAL NFC CRYOCATH TECHNOLOGIES, INC. 229F5 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention