BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLANAV OI

    MDR report key: 7619658 · Received June 20, 2018

    Report

    Report Number
    2134265-2018-05527
    Event Type
    Malfunction
    Date Received
    June 20, 2018
    Date of Event
    April 25, 2018
    Report Date
    May 30, 2018
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (HEREDIA)
    Product Code
    OAE
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED A KINK AT THE BUTT BOND WITH DRIED BODY FLUID NOTED IN THE SEAM WHERE THE TWO SECTIONS MEET. ANOTHER KINK FOUND AT 43CM FROM THE END OF THE DISTAL TIP. DRIED BODY FLUIDS WERE FOUND ON THE HANDLE, MAIN BODY TUBING AND ON THE DISTAL END. CONTINUITY CHECKS REVEALED NO ELECTRICAL OPENS, AS CHECKED MANUALLY USING A MULTI-METER AND BREAKOUT BOX. NUMEROUS ELECTRICAL SHORTS WERE FOUND: RES ID TO TC+ & TC-, RES ID TO TIP, RES ID TO RING 3, RES ID TO SENSOR 1 & 2, GND TO TC+ & TC-, GND TO TIP, GND TO RING 3, GND TO SENSOR 1 & 2, TC+ TO TIP, TC + TO RING 3, TC+ TO SENSOR 1 & 2, TC+ TO TIP, TC-TO TIP, TC - TO RING 3, TC- TO SENSOR 1 & 2, TIP TO SENSOR 1 & 2, RING 3 TO SENSOR 1 & 2. ALL ELECTRODE/THERMOCOUPLE/SENSOR RESISTANCES MEASURED IN SPECIFICATION AND WERE TYPICAL. LCR TEST WAS PERFORMED AND CONFIRMED THAT THE MAGNETIC SENSOR WAS WITHIN SPECIFICATIONS. THE STEERING KNOB AND THE TENSION CONTROL KNOB FUNCTIONED PROPERLY ON BOTH LOCK AND UNLOCK POSITIONS. NO ABNORMAL RESISTANCE WAS FELT WHEN ACTUATING THE STEERING MECHANISM. X-RAY FOUND A COLLAPSED GUIDE COIL UNDER THE STRAIN RELIEF AND THROUGHOUT THE MAIN BODY TUBING. THE CENTER SUPPORT WAS BENT AT APPROXIMATELY 43CM FROM THE DISTAL TIP, AND AT THE BUTT BOND. UNKNOWN DEBRIS WAS FOUND BETWEEN RINGS 1 & 2. THE DISTAL END WAS DISSECTED BETWEEN THE BUTT BOND AND THE DISTAL TIP. THE ENTIRE CAVITY WAS FILLED WITH DRIED BODY FLUID, WITH LARGER CHUNKS LOCATED THROUGHOUT THE RING AREA. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE INVESTIGATION CONCLUSION IS DESIGN SPECIFICATION AS THE DEVICE PROBLEM WAS TRACED BACK TO THE DESIGN SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30MAY2018. IT WAS REPORTED THAT NOISE OCCURRED. DURING A RIGHT VENTRICULAR OUTFLOW TRACT TACHYCARDIA (RVOT/AT) ABLATION PROCEDURE WITH AN INTELLANAV OI ABLATION CATHETER, THE CATHETER WAS INSERTED INTO THE LEFT ATRIUM AND MAPPED WELL WITH NO ISSUES. THEN, NOISE BECAME APPARENT. THE CATHETER CABLE WAS CHANGED, WHICH MADE NO DIFFERENCE. THEN, THE CATHETER WAS REPLACED WITH THE SAME TYPE, THE NOISE RESOLVED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS OCCURRED AND THE PATIENT WAS STABLE. DEVICE ANALYSIS REVEALED A SEVERE KINK DISTAL TO THE BUTT BOND, WHICH CAUSED A CRACK TO OPEN IN THE BUTT BOND SEAL, ALLOWING BODY FLUID TO ENTER THE INTERIOR OF THE MAIN BODY TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463371 INTELLANAV OI INTELLANAV OI OAE BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) M004EPTR9620K20 20857600

    Patients

    Seq Age Sex Outcome Treatment
    1