BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, SMALL CURL

    MDR report key: 2548118 · Received November 26, 2008

    Report

    Report Number
    2182269-2008-00244
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 26, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEFT PULMONARY VEIN ISOLATION AND RIGHT PULMONARY VEIN ISOLATION WERE PERFORMED WITHOUT COMPLICATION. AFTER RIGHT PULMONARY VEIN ISOLATION, THE PATIENT'S BLOOD PRESSURE DROPPED TO THE FIFTIES AND THE ABLATION CASE WAS COMPLETED. FOLLOWING THE CASE, AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED A TAMPONADE. THE TAMPONADE WAS TREATED BY CARDIAC DRAINAGE. THE PATIENT RECOVERED WITHOUT COMPLICATIONS. THE PHYSICIAN STATED THAT THE CAUSE OF THE TAMPONADE WAS INCONCLUSIVE. THE PHYSICIAN HAD BEEN TRAINED ON THE USAGE OF THE DEVICE PRIOR TO THE PROCEDURE. OTHER DEVICES USED DURING THE PROCEDURE INCLUDE ABLAZE FANTASISTA, JLL, IBI 20MM (DECAPOLAR), IBI STEERABLE, DUO DECAPOLAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS NXT, 8.5F, STEERABLE INTRODUCER, SMALL CURL AGILIS NXT, 8.5F DYB ST. JUDE MEDICAL NA 2082068

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK