BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 5 MM TIP UNIVERSAL TEMPERATURE MONITORI

    MDR report key: 4213881 · Received October 30, 2014

    Report

    Report Number
    3005188751-2014-00131
    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
    LPB
    PMA / PMN Number
    PP960016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ONE SAFIRE BLU DUO ABLATION CATHETER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED THREE BENDS ON THE CATHETER SHAFT. THE RESULTS OF THE INVESTIGATION CONCLUDED THAT THE CATHETER DEFLECTED IN BOTH DIRECTIONS BUT NO LONGER DEFLECTED IN THE CORRECT SHAPE AND NO LONGER MET SPECIFICATIONS IN ONE DIRECTION, DUE TO THREE BENDS AND ONE KINK IN THE SHAFT. NO ANOMALIES WERE NOTED ON THE DISTAL TIP. THE DEVICE HISTORY RECORD FOR THE ABOVE-REFERENCED PRODUCT WAS UNABLE TO BE REVIEWED SINCE THE BATCH NUMBER IS UNKNOWN. THE CAUSE OF THE BENDS AND THE KINK IN THE SHAFT IS CONSISTENT WITH FORCIBLE CONTACT DURING USE. THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION REMAINS UNKNOWN. VASCULAR PERFORATION OR DISSECTION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE 3005188751-2014-00132, 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
    697525 SAFIRE¿ BI-DIRECTIONAL ABLATION CATHETER 5 MM TIP UNIVERSAL TEMPERATURE MONITORI CATHETER, PERCUTANEOUS CARDIAC ABLATION LPB ST. JUDE MEDICAL, INC. 402816

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SWARTZ BRAIDED TRANSSEPTAL INTRODUCER| REFLEXION SPIRAL EP CATHETER