BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWARTZ BRAIDED INTRODUCER, 8.5F, SL1

    MDR report key: 3812506 · Received May 5, 2014

    Report

    Report Number
    3005188751-2014-00073
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 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 CARDIAC TAMPONADE COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, VASCULAR PERFORATION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 2030404-2014-00050, 3005188751-2014-00070. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A BRK TRANSSEPTAL NEEDLE AND A SWARTZ BRAIDED TRANSSEPTAL INTRODUCER WAS ADVANCED INTO THE LEFT ATRIUM. AFTER CREATING THE MODEL WITH AN INQUIRY OPTIMA EP CATHETER, A TACTICATH QUARTZ ABLATION CATHETER WAS ADVANCED INTO THE LEFT ATRIUM. PRIOR TO ABLATION, THE PATIENT BECAME HYPOTENSIVE AND IT WAS NOTED ON FLUOROSCOPY THE CARDIAC SILHOUETTE SHOWED REDUCED MOVEMENT, WHICH INDICATED A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. NO FURTHER INTERVENTION WAS NECESSARY. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267921 SWARTZ BRAIDED INTRODUCER, 8.5F, SL1 DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 407453 4261973

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INQUIRY OPTIMA EP CATHETER, (81767/4385377)| BARD CATHETER, (MODEL/LOT UNK)| BRK TRANSSEPTAL NEEDLE, (407200/LOT UNK)| TACTICATH QUARTZ ABLATION CATHETER, (PN-004065)