BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REFLEXION¿ SPIRAL VARIABLE RADIUS CATHETER 6F LOOP BI-DIRECTIONAL

    MDR report key: 4213896 · Received October 30, 2014

    Report

    Report Number
    3005188751-2014-00132
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    PMA / PMN Number
    PK072012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION 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 MANUFACTURER REFERENCE 3005188751-2014-00131, 3005188751-2014-00133. DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, A PERICARDIAL EFFUSION OCCURRED. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH A NON-SJM TRANSSEPTAL NEEDLE THROUGH A SWARTZ BRAIDED TRANSSEPTAL INTRODUCER. A REFLEXION SPIRAL EP CATHETER WAS USED FOR MAPPING AND ABLATION WAS PERFORMED USING A SAFIRE ABLATION CATHETER. AFTER ABLATING FOR APPROXIMATELY 1.5 HOURS AND DURING ABLATION AT THE LEFT PULMONARY VEINS, A PERICARDIAL EFFUSION WAS NOTED VIA A VIEWFLEX XTRA ICE CATHETER; HOWEVER, THERE WERE NO PATIENT SYMPTOMS EXCEPT MILD HYPOTENSION. A PERICARDIOCENTESIS WAS PERFORMED. IT WAS UNKNOWN WHICH DEVICE CONTRIBUTED TO THE EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697577 REFLEXION¿ SPIRAL VARIABLE RADIUS CATHETER 6F LOOP BI-DIRECTIONAL CATHETER, ELECTRODE RECORDING DRF ST. JUDE MEDICAL, INC. D402893

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SWARTZ BRAIDED TRANSSEPTAL INTRODUCER| SAFIRE ABLATION CATHETER