BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARTZ BRAIDED TRANS INTRODUCER, 8.5F, SLO, 63CM

    MDR report key: 3240329 · Received July 18, 2013

    Report

    Report Number
    3005188751-2013-00071
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ST. JUDE MEDICAL (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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 MFG AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECS AND PROCEDURES. BASED ON THE INFO RECEIVED, THE CAUSE OF THE REPORTED CARDIAC PERFORATION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN INHERENT RISK OF A TRANSSEPTAL PUNCTURE PROCEDURE.

    Description of Event or Problem · 1

    RELATED MFR REFERENCE: 2030404-2013-00052, 3005188751-2013-00069, 00071, 00072. DURING A PULMONARY VEIN ISOLATION (PVI) ABLATION PROCEDURE USING A THERAPY COOL PATH ABLATION CATHETER, A PERICARDIAL EFFUSION OCCURRED. AN EPICARDIAL HYBRID USING A N-CONTACT DEVICE WAS COMPLETED PRIOR TO THE ENDOCARDIAL ABLATION PROCEDURE. A LIVEWIRE DUO-DECA CATHETER WAS PLACED INTO THE CORONARY SINUS. THE PHYSICIAN PERFORMED A DOUBLE TRANSSEPTAL PUNCTURE WITH A BRK TRANSSEPTAL NEEDLE AND TWO SWARTZ BRAIDED TRANSSEPTAL INTRODUCERS. THE THERAPY COOL PATH ABLATION CATHETER AND A REFLEXION SPIRAL DIAGNOSTIC CATHETER WERE ADVANCED INTO THE LEFT ATRIUM. ABLATION WAS PERFORMED SUCCESSFULLY ON THE LEFT SUPERIOR PULMONARY VEIN AND THE PHYSICIAN BEGAN ABLATION ON THE LEFT INFERIOR PULMONARY VEIN, AT WHICH POINT THE PT WAS NOTED TO BE HYPOTENSIVE. AN EXTERNAL ULTRASOUND WAS PERFORMED, REVEALING A PERICARDIAL EFFUSION, WHICH WAS CONFIRMED VIA TRANSESOPHAGEAL ECHOCARDIOGRAM. THE CARDIAC PERFORATION WAS LOCATED ON THE SUPERIOR ASPECT OF THE LEFT PULMONARY VEINS IN THE AREA OF THE LIGAMENTUM OF MARSHALL. THE PHYSICIAN AND HIS PARTNER PERFORMED A PERICARDIOCENTESIS WHICH STABILIZED THE PT. THE PT WAS TAKEN TO THE OPERATING ROOM FOR A PERICARDIAL WINDOW AND A SUTURE REPAIR OF THE PERFORATION. THE PT REMAINED STABLE AFTER SURGERY. THE PHYSICIAN STATED THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336075 SWARTZ BRAIDED TRANS INTRODUCER, 8.5F, SLO, 63CM TRANSSEPTAL CATHETER INTRODUCER DYB ST. JUDE MEDICAL (AF-MINNETONKA) 407451 4025934

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention BRK TRANSSEPTAL NEEDLE: ((B)(4))| REFLEXION SPIRAL CATHETER: ((B)(4))| SWARTZ BRAIDED TRANSSEPTAL INTRODUCER:| ENSITE VELOCITY SYSTEM| ((B)(4))| LIVEWIRE DUO-DECA CATHETER: ((B)(4))| COOL PATH CATHETER: ((B)(4))