BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH

    MDR report key: 4310997 · Received December 9, 2014

    Report

    Report Number
    3008452825-2014-00053
    Event Type
    Death
    Date Received
    December 9, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 13, 2014
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DRC
    PMA / PMN Number
    PK072278
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION AND SUBSEQUENT DEATH COULD NOT BE CONCLUSIVELY DETERMINED PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 1

    RELATED MFR REFERENCE 3005188751-2014-00144, 3005188751-2014-00145, 3005188751-2014-00146, 3005188751-2014-00147, 3005188751-2014-00148, 3005188751-2014-00149. DURING A PULMONARY VEIN ISOLATION PROCEDURE, A PERICARDIAL EFFUSION AND SUBSEQUENT DEATH OCCURRED. A LIVEWIRE EP CATHETER WAS PLACED IN THE RIGHT ATRIUM, AND A SUPREME QUADRIPOLAR EP CATHETER IN THE HIS. A BRK TRANSSEPTAL NEEDLE THROUGH A FAST CATH TRANSSEPTAL INTRODUCER WAS USED TO PERFORM A TRANSSEPTAL PUNCTURE AND A REFLEXION SPIRAL EP CATHETER WAS ADVANCED INTO THE LEFT ATRIUM FOR MAPPING PURPOSES. A SECOND TRANSSEPTAL PUNCTURE WAS PERFORMED WITH ANOTHER BRK TRANSSEPTAL NEEDLE THROUGH A SECOND FAST CATH TRANSSEPTAL INTRODUCER AND A NON-SJM ABLATION CATHETER WAS ADVANCED INTO THE LEFT ATRIUM. IT WAS NOTED THIS CATHETER APPEARED OUTSIDE OF THE GEOMETRY. AFTER FURTHER MANIPULATION OF THE CATHETER, THE PATIENT BECAME HYPOTENSIVE AND AN ECHOCARDIOGRAM REVEALED A PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED BUT THE PATIENT¿S CONDITION DETERIORATED AND CPR WAS INITIATED. THIS WAS UNSUCCESSFUL AND THE PATIENT SUBSEQUENTLY EXPIRED. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793241 BRK? TRANSSEPTAL NEEDLE, 71 CM LENGTH TRANSSEPTAL NEEDLE DRC ST. JUDE MEDICAL 407200 4674822

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| R SUPREME QUADRIPOLAR EP CATHETER| FAST CATH TRANSSEPTAL INTRODUCER X2| REFLEXION SPIRAL EP CATHETER| LIVEWIRE DUO-DECAPOLAR EP CATHETER| BIOSENSE WEBSTER ICE CATHETER| BRK TRANSSEPTAL NEEDLE| BIOSENSE WEBSTER THERMOCOOL ABLATION CATHETER