BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 98CM

    MDR report key: 2175655 · Received July 19, 2011

    Report

    Report Number
    3005188751-2011-00126
    Event Type
    Injury
    Date Received
    July 19, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER FOR THE DEVICE IS UNKNOWN. THE ROOT CAUSE CLASSIFICATION 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 INCIDENT AS MFR REPORT NUMBERS: 2030404-2011-00215, 2030404-2011-00217, 2030404-2011-00216, 3005188751-2011-00125, 3005188751-2011-00124. IT WAS REPORTED AFTER COMPLETION OF AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION. ONE HOUR AFTER THE ABLATION PROCEDURE WAS COMPLETED, THE PATIENT'S BLOOD PRESSURE DECREASED. AN ECHOCARDIOGRAM WAS PERFORMED WHICH CONFIRMED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED AND 100 CC OF BLOOD WAS REMOVED FROM THE PERICARDIUM. THE CURRENT STATUS OF THE PATIENT IS LISTED AS "HEALTHY." THE PHYSICIAN IS UNCERTAIN AS TO THE CAUSE FOR THE REPORTED PERICARDIAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSSEPTAL NEEDLE, BRK SERIES, ADULT 18 GA, 98CM BRK XS NEEDLE DRC ST. JUDE MEDICAL, AF DIVISION 407206 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R AGILIS NXT STEERABLE INTRODUCER: MODEL 408309| THERAPY COOL FLEX: MODEL 88015| ESOTHERM PLUS CATHETER: MODEL 26155S| TWO FAST-CATH HEMOSTASIS INTRODUCERS: MODEL 406204| MAXIMUM HEMOSTASIS INTRODUCER: MODEL 406259| TWO 10 PIN CONNECTING CABLES: MODEL 85954| 1500T GENERATOR CONNECTING CABLE: MODEL 85641| FAST-CATH HEMOSTASIS INTRODUCER: MODEL 406200| AGILIS NXT STEERABLE INTRODUCER: MODEL 406128| SUPREME EP CATHETER: MODEL 401891| INQUIRY OPTIMA STEERABLE: MODEL 81687| INQUIRY STEERABLE CATHETER: MODEL 81107