BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER

    MDR report key: 3770101 · Received April 24, 2014

    Report

    Report Number
    2134265-2014-02137
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 28, 2014
    Report Date
    March 28, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    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 MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE DEVICE HAS SEVERE CHAR AT THE TIP, AND THE THIRD RING ADHESIVE IS LIFT AND IT HAS A BUBBLE. THE RF ABLATION TEST WAS PERFORMED AND THE DEVICE DISPLAYED D10 ERROR. THE DEVICE PASSED THE ELECTRICAL TEST. THE HANDLE WAS OPENED AND IT WAS FOUND THAT THE RECEPTACLE WAS WIRED IMPROPERLY SINCE THE SHORT RESISTOR LEAD WAS ASSEMBLED IN PIN #10 INSTEAD OF PIN #11, AND THE LONG RESISTOR LEAD WAS ASSEMBLED IN PIN #11 INSTEAD OF PIN #10. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED MANUFACTURING, CORRECTIVE ACTION HAS BEEN COMPLETED IN ORDER TO ADDRESS THE IDENTIFIED ISSUE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER ABLATION TREATMENT PROCEDURE, CHAR OCCURRED. THE LESION WAS LOCATED IN THE RIGHT ATRIUM. THIS INTELLATIP MIFI XP TEMPERATURE ABLATION CATHETER AND A MAESTRO 3000 GENERATOR WERE SELECTED. THE ABLATION PARAMETERS WERE SET AT 100W, 60 DEGREES, 300 OHMS, 120 SECONDS. THE AVERAGE POWER WAS 70WATTS AND TEMPERATURE WAS 53 DEGREES. THE DURATION OF THE RF ABLATION WAS ONE APPLICATION OF 120 SECONDS, ONE APPLICATION OF 42 SECONDS COMPLETED IN TEMPERATURE MODE. TWO GROUNDING PADS WERE PLACED ONE ON BACK BEHIND HEART, ONE ON FRONT. DURING THE PROCEDURE THE GENERATOR TURNED OFF AND THE CATHETER DISPLAYED AN ERROR MESSAGE. AFTER INSPECTION OF THE CATHETER, CHAR WAS FOUND ON THE TIP AFTER ONLY 4 MINUTES OF ABLATING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FLUTTER ABLATION TREATMENT PROCEDURE, CHAR OCCURRED. THE LESION WAS LOCATED IN THE RIGHT ATRIUM. THIS INTELLATIP MIFI¿ XP TEMPERATURE ABLATION CATHETER AND A MAESTRO 3000 GENERATOR WERE SELECTED. THE ABLATION PARAMETERS WERE SET AT 100W, 60 DEGREES, 300 OHMS, 120 SECONDS. THE AVERAGE POWER WAS 70WATTS AND TEMPERATURE WAS 53 DEGREES. THE DURATION OF THE RF ABLATION WAS ONE APPLICATION OF 120 SECONDS, ONE APPLICATION OF 42 SECONDS COMPLETED IN TEMPERATURE MODE. TWO GROUNDING PADS WERE PLACED ONE ON BACK BEHIND HEART, ONE ON FRONT. DURING THE PROCEDURE THE GENERATOR TURNED OFF AND THE CATHETER DISPLAYED AN ERROR MESSAGE. AFTER INSPECTION OF THE CATHETER, CHAR WAS FOUND ON THE TIP AFTER ONLY 4 MINUTES OF ABLATING. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249347 INTELLATIP MIFI? XP TEMPERATURE ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) M004PM4500K20 16573563

    Patients

    Seq Age Sex Outcome Treatment
    1