BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER

    MDR report key: 3881330 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03479
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 21, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    OAD
    PMA / PMN Number
    P020025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE PASSED THE ELECTRICAL AND RF ABLATION TESTS. THE LEFT CURVE IS PLACED IN THE TEMPLATE SHADED AREA. HOWEVER, THE DEVICE HAS A KINK AT THE DISTAL SECTION, AND THE RIGHT CURVE IS NOT PLACED IN THE TEMPLATE SHADED AREA, THE DEVICE WAS DISSECTED FINDING THE CENTER SUPPORT KINKED AT THE DISTAL SECTION. IN ADDITION THE ADHESIVE IS LIFTED AT THE RING 2, AND THERE IS EVIDENCE OF BLOOD UNDER THE ADHESIVE, PROBABLY PRODUCED DUE TO THE MANIPULATION DURING THE PROCEDURE. THIS BLOOD INSIDE THE DEVICE COULD CAUSE NOISE ISSUES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE UPON ANALYSIS COMPLETED ON (B)(4) 2014. IT WAS REPORTED THAT DURING AN ARTERIAL FLUTTER ABLATION PROCEDURE A STEERING WIRE BROKE AND NOISE WAS EXPERIENCED. WHILE USING A INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER TO TREAT THE VENA CAVA TRICUSPID ISTHMUS IT IS WAS NOTED THAT THE STEERING WIRE BROKE AND THE ELECTRODES WERE NOISY. THE DEVICE WAS SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A LARGE CURVE MODEL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. DEVICE ANALYSIS REVEALED THAT A RING ADHESIVE WAS LIFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357307 INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M004PM4500N40 16615976

    Patients

    Seq Age Sex Outcome Treatment
    1