BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    MDR report key: 2536032 · Received April 6, 2012

    Report

    Report Number
    3005188751-2012-00108
    Event Type
    Injury
    Date Received
    April 6, 2012
    Date of Event
    March 15, 2012
    Report Date
    March 15, 2012
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE COMPLETED. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE OF THE TAMPONADE IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    SAME CASE AS: 2030404-2012-00104, 2030404-2012-00105, AND 2030404-2012-00109. IT WAS REPORTED THAT AFTER A PULMONARY, VEIN ISOLATION (PVI) CRYOABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. AFTER COMPLETION OF THE PVI IN THE LEFT ATRIUM, THE PT WAS STABLE. THE PHYSICIAN PERFORMED AN ELECTROPHYSIOLOGY STUDY ON THE RIGHT SIDE USING AN 8.5F AGILIS NXT INTRODUCER, ONE SUPREME EP CATHETER AND TWO INQUIRY STEERABLE CATHETERS. TOWARDS THE END OF THE CASE, IT WAS NOTED THAT THE PT'S HEART RATE INCREASED AND THE PT BECAME HYPOTENSIVE. ECHOCARDIOGRAPHY CONFIRMED A PERICARDIAL EFFUSION, AND A PERICARDIAL TAP WAS PERFORMED. A PERICARDIAL WINDOW WAS ALSO PERFORMED REVEALING THE PERFORATION WAS LOCATED IN THE RIGHT ATRIUM POSTERIOR TO THE CORONARY SINUS. THE PT WAS STABLE AND DISCHARGED TWO DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL AGILIS NXT, 8.5 MED CRL DYB ST. JUDE MEDICAL, AF DIVISION 408310 3587805

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention MEDTRONIC ACHIEVE| MEDTRONIC ARTIC FRONT| NAVX VELOCITY 2.1| MEDTRONIC FLEX CATHETER| PRODUCT ID# (B)(4), LOT# 3553775| SUPREME EP CATHETER, 6F, QUADRIPOLAR:| ACCUNAV| BAYLIS NEEDLE| INQUIRY STEERABLE CATHETER 6F:| PRODUCT ID# (B)(4), LOT# 3614027| INQUIRY STEERABLE CATHETER 6F:| PRODUCT ID# (B)(4), LOT# 3614052