BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAFIRE¿ BLU¿ DUO ABLATION CATHETER

    MDR report key: 4213610 · Received October 30, 2014

    Report

    Report Number
    2030404-2014-00098
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    OAD
    PMA / PMN Number
    PP110016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SAFIRE BLU DUO ABLATION CATHETER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED BENDS ON THE GRAY SHAFT 0.82¿ AND 2.30¿ PROXIMAL TO THE DISTAL TIP. THE BLUE SHAFT HAD A SLIGHTLY WAVY APPEARANCE AND NO OTHER VISUAL ANOMALIES WERE NOTED. THE RESULTS OF THE INVESTIGATION CONCLUDED THAT THE CATHETER MET SPECIFICATIONS OF ACCEPTABLE RESISTANCE READINGS IN THE DEFLECTED, UNDEFLECTED AND MANIPULATED STATES. DURING ABLATION SIMULATION AN OCCL ERROR WAS OBSERVED. THE CATHETER SHAFT WAS DISSECTED AND THE FLUID LUMEN WAS FOUND TO BE TWISTED, WHICH IS CONSISTENT WITH DAMAGE DURING USE. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING SJM MANUFACTURING FACILITIES AS SUPPORTED BY A REVIEW OF THE DEVICE HISTORY RECORD. THE CAUSE OF THE REPORTED CARDIAC PERFORATION MAY HAVE BEEN PROCEDURE RELATED. PER THE IFU, VASCULAR PERFORATION OR DISSECTION IS AN INHERENT RISK OF ANY ELECTRODE PLACEMENT.

    Description of Event or Problem · 1

    DURING A RIGHT VENTRICULAR OUTFLOW TRACT ABLATION (RVOT) PROCEDURE USING A SAFIRE BLU DUO ABLATION CATHETER, A CARDIAC PERFORATION OCCURRED. WHILE MAPPING AND ABLATING A PREVENTRICULAR CONTRACTION (PVC) IN THE RVOT, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE DUE TO A CARDIAC TAMPONADE. A PERICARDIOCENTESIS WAS PERFORMED, WHICH STABILIZED THE PATIENT. THE PATIENT WAS THEN PLACED UNDER OBSERVATION. THERE WERE NO PERFORMANCE ISSUES WITH ANY SJM DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695699 SAFIRE¿ BLU¿ DUO ABLATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, INC. A700240 4717368

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R LIVEWIRE EP CATHETER, MEDIGUIDE ENABLED| ENSITE VELOCITY MAPPING SYSTEM