BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSSEPTAL NEEDLE, BRK XS, ADULT 18 GA, 71CM

    MDR report key: 3032226 · Received March 29, 2013

    Report

    Report Number
    3005188751-2013-00049
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFO RECEIVED, THE ROOT CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS AN INHERENT RISK OF ANY TRANSSEPTAL PROCEDURE.

    Description of Event or Problem · 1

    RELATED MFR REFERENCE: 2030404-2013-00024, 2030404-2013-00025, 3005188751-2013-00047, 3005188751-2013-00048. DURING A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE PERFORMED USING A SAFIRE BLU DUO ABLATION CATHETER, A CARDIAC PERFORATION OCCURRED. THE PHYSICIAN PLACED AN INQUIRY STEERABLE DIAGNOSTIC CATHETER IN THE CORONARY SINUS FOR MAPPING PURPOSES AND PERFORMED TRANSSEPTAL PUNCTURE WITH A FAST CATH TRANSSEPTAL GUIDING INTRODUCER AND A BRK TRANSSEPTAL NEEDLE. THE FAST CATH INTRODUCER WAS THEN REPLACED WITH A SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, THROUGH WHICH THE SAFIRE BLU CATHETER WAS ADVANCED INTO THE LEFT VENTRICLE TO CREATE GEOMETRY. APPROXIMATELY 20 MINUTES INTO MAPPING, THE PT BECAME HYPOTENSIVE. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED, REVEALING A PERICARDIAL EFFUSION. PROTAMINE WAS ADMINISTERED AND THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS TO STABILIZE THE PT. THE PHYSICIAN WAS UNABLE TO DETERMINE THE LOCATION OR TIME OF THE PERFORATION BUT INDICATED NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130067 TRANSSEPTAL NEEDLE, BRK XS, ADULT 18 GA, 71CM TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL, INC. (AF-MINNETONKA) G407208 3896062

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention SAFIRE BLU DUO ABLATION CATHETER (A088018/3854004)| INQUIRY STEERABLE DIAGNOSTIC CATHETER| BRAIDED SWARTZ INTRODUCER (407362/3918372)| FAST CATH INTRODUCER (406843/3308354)| (81105/3841818)