BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL

    MDR report key: 3553421 · Received December 20, 2013

    Report

    Report Number
    3005188751-2013-00117
    Event Type
    Injury
    Date Received
    December 20, 2013
    Date of Event
    November 25, 2013
    Report Date
    November 25, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-IRVINE)
    Product Code
    DYB
    PMA / PMN Number
    K061363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE: 2030404-2013-00114, 2030404-2013-00115, 2030404-2013-00116. DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. AN INITIAL DIAGNOSTIC STUDY WAS PERFORMED UNDER GENERAL ANESTHESIA, THE PATIENT WAS INTUBATED AND ON AN ISUPREL IV DRIP. A TRANSSEPTAL PUNCTURE WAS PERFORMED AN AGILIS NXT INTRODUCER AND NON-SJM TRANSSEPTAL NEEDLE. AN INQUIRY STEERABLE QUADRIPOLAR CATHETER WAS PLACED IN THE RIGHT VENTRICLE, AN INQUIRY STEERABLE DECAPOLAR CATHETER WAS PLACED IN THE CORONARY SINUS, AND A SAFIRE BLU DUO ABLATION CATHETER WAS PLACED IN THE LEFT VENTRICLE. GEOMETRY WAS COLLECTED IN THE LEFT VENTRICLE USING THE SAFIRE BLU DUO ABLATION CATHETER. WHILE THE COMPLETED MAP WAS BEING ANALYZED, THE PATIENT BECAME HYPOTENSIVE. THE VIEWFLEX ICE CATHETER REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. THE PATIENT LEFT THE LAB INTUBATED BUT HEMODYNAMICALLY STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669401 AGILIS NXT, 8.5F, STEERABLE INTRODUCER, MED CURL DYB ST. JUDE MEDICAL, INC. (AF-IRVINE) 408310 4163675

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention (B)(4)| NON-SJM TRANSSEPTAL NEEDLE| (B)(4)| VIEWFLEX XTRA ICE CATHETER| (B)(4)| INQUIRY STEERABLE DECAPOLAR EP CATHETER| INQUIRY STEERABLE QUADRIPOLAR EP CATHETER| (B)(4)| SAFIRE BLU DUO ABLATION CATHETER| ENSITE VELOCITY MAPPING SYSTEM| (B)(4)