BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRO., 8F, SL1

    MDR report key: 2010728 · Received March 2, 2011

    Report

    Report Number
    3005188751-2011-00026
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 7, 2011
    Manufacturer
    ST. JUDE MEDICAL, AF DIVISION
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL AND FUNCTIONAL TESTING OF THE RETURNED INTRODUCE/DILATOR REVEALED NO ABNORMALITIES. THE DILATOR WAS INSERTED AND ADVANCED THROUGH THE ENTIRE LENGTH OF THE INTRODUCER AND SNAPPED INTO THE HUB WITH NO ABNORMAL RESISTANCE ENCOUNTERED MICROSCOPIC INSPECTION REVEALED NO ABNORMAL SURFACE ANOMALIES IN THE INTRODUCER OR DILATOR. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. THE CAUSE FOR THE REPORTED EVENT REMAINS UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE BEGINNING OF AN ATRIAL FIBRILLATION ABLATION PROCEDURE, THE PHYSICIAN INTRODUCED A CS CATHETER AND AN ABLATION CATHETER INTO THE HEART. THE ABLATION CATHETER WAS USED TO MARK THE HIS. THE INTRODUCER AND DILATOR WERE INSERTED INTO THE RIGHT ATRIUM. AS THIS WAS THE PATIENT'S SECOND ATRIAL FIBRILLATION ABLATION PROCEDURE, IT WAS KNOWN THAT THE PT HAD A PFO. INTRACARDIAC ECHOCARDIOGRAPHY WAS NOT USED FOR THIS PROCEDURE. WITHOUT USING THE TRANSSEPTAL NEEDLE, THE SHEATH AND DILATOR EASY ADVANCED INTO WHAT APPEARED TO BE THE LEFT ATRIUM THROUGH THE PFO. WHEN THE DILATOR WAS REMOVED, THE SHEATH SEEMED TO DROP DOWN SLIGHTLY AND WHEN DYE WAS INJECTED, THE INTRODUCER DID NOT APPEAR TO BE IN THE LEFT ATRIUM AS INTENDED. THE PHYSICIAN SUSPECTED A POSSIBLE PUNCTURE INTO THE PERICARDIAL SPACE OR THE AORTA. THE PATIENT'S BLOOD PRESSURE WAS STABLE AND AFTER ASSESSING THE SITUATION WITH TEE AND FLUOROSCOPY, IT WAS DETERMINED A SMALL PUNCTURE WAS MADE INTO THE THICK TISSUE BETWEEN THE SVC AND THE AORTA. THE PT DEVELOPED NO SYMPTOMS, REMAINED STABLE AND NO TAMPONADE WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PT AND NO INTERVENTION WAS REQUIRED TO CORRECT THE PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRO., 8F, SL1 SWARTZ INTRODUCER, SL1 DYB ST. JUDE MEDICAL, AF DIVISION 407439 2859645

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (83563, LOT 3184461)| COOL PATH DUO ABLATION CATHETER| (81174, LOT K24287)| INQUIRY STEERABLE 5F EP CATHETER