BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRK XS, TRANSSPETAL NEEDLE, 89CM

    MDR report key: 3567577 · Received December 27, 2013

    Report

    Report Number
    3005188751-2013-00123
    Event Type
    Injury
    Date Received
    December 27, 2013
    Date of Event
    December 3, 2013
    Report Date
    December 3, 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

    METHOD: 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. THE PHYSICIAN INDICATED THE NEEDLE PERFORATED THE AORTA DURING TRANSSEPTAL PUNCTURE. PER THE IFU, CARDIAC PERFORATION IS A KNOWN INHERENT RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    DURING A CARDIAC ABLATION PROCEDURE USING A BRK TRANSSEPTAL NEEDLE, A CARDIAC PERFORATION OCCURRED. DURING THE TRANSSEPTAL PUNCTURE, THE BRK TRANSSEPTAL NEEDLE WAS ADVANCED THROUGH THE ATRIAL WALL INTO THE AORTA, WHICH WAS CONFIRMED BY CONTRAST AND AN ECHOCARDIOGRAM. THE PATIENT REMAINED STABLE WITH NO BLOOD PRESSURE DECREASE OR RESPIRATORY DISTRESS. ALL CATHETERS WERE KEPT IN PLACE AND A CARDIAC SURGEON WAS CONSULTED. A STERNOTOMY WAS PERFORMED FOR REMOVAL OF ALL DEVICES AND TO ASSESS THE PERFORATION; NO TAMPONADE OR PERICARDIAL EFFUSION WAS NOTED AND THE PATIENT REMAINED STABLE. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677631 DRK XS, TRANSSPETAL NEEDLE, 89CM DRC ST. JUDE MEDICAL, INC (AF-MINNETONKA) G407210 4064262

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention INQUIRY DECAPOLAR CATHETER,| (B)(4)| (B)(4)| SWARTZ BRAIDED TRANSSEPTAL INTRODUCER,