BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2994369 · Received March 5, 2013

    Report

    Report Number
    3005188751-2013-00030
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DRC
    PMA / PMN Number
    K072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION OF THE REPORTED CARDIAC TAMPONADE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AS STATED IN THE IFU.

    Description of Event or Problem · 1

    RELATED TO MFR REF 3005188751-2013-00011. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE PERFORMED WITH A THERAPY COOL FLEX ABLATION CATHETER, A CARDIAC PERFORATION OCCURRED. TRANSSEPTAL PUNCTURE WAS PERFORMED USING A BRK TRANSSEPTAL NEEDLE. THE COOL FLEX ABLATION CATHETER AND A REFLEXION SPIRAL DIAGNOSTIC CATHETER WERE ADVANCED INTO THE LEFT ATRIUM AND GEOMETRY WAS COLLECTED FOLLOWED BY RADIOFREQUENCY ABLATION. NEAR THE CONCLUSION OF THE PROCEDURE, THE PATIENT BECAME HYPOTENSIVE AND ULTRASOUND REVEALED A CARDIAC TAMPONADE, THE PHYSICIAN PERFORMED A PERICARDIOCENTESIS, WHICH STABILIZED THE PATIENT. THE PATIENT HAS RECOVERED FROM THE CARDIAC TAMPONADE. THE PHYSICIAN INDICATED THAT THE PERFORATION MOST LIKELY OCCURRED DURING TRANSSEPTAL PUNCTURE OR WHILE ABLATING IN THE LEFT ATRIUM. HE ALSO INDICATED THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94327 TRANSSEPTAL NEEDLE, BRK XS, ADULT 18 GA, 71CM TNANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL, INC. (AF-MINNETONKA) G407208 3891060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention