BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM

    MDR report key: 9795062 · Received March 5, 2020

    Report

    Report Number
    2029046-2020-00355
    Event Type
    Malfunction
    Date Received
    March 5, 2020
    Date of Event
    January 16, 2020
    Report Date
    January 16, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS VISUALLY INSPECTED, AND VALVE AND FRICTION RING WERE FOUND DISLODGED INTO HUB. THE VALVE AND FRICTION RING COULD HAVE BEEN DETACHED DUE TO AN EXTERNAL FORCE WHILE INSERTING THE DEVICE THRU THE SHEATH, BUT THIS COULD NOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 00001189 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED. MANUFACTURER'S REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM FOR WHICH THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB IDENTIFIED A HEMOSTATIC VALVE SEPARATION OCCURRED AND FRICTION RING DISLODGMENT. INITIALLY IT WAS REPORTED THAT DURING USE, THE VALVE ON THE VIZIGO SHEATH WAS LEAKING BLOOD EVEN AFTER PULLING IT STRAIGHT OUT INSTEAD OF TWISTING ON THE DILATOR. THE VIZIGO SHEATH WAS REPLACED WITH ANOTHER NON-BIOSENSE WEBSTER, INC. SHEATH AND THE PROCEDURE CONTINUED. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED, AND NO EXTENDED HOSPITALIZATION WAS NEEDED. THERE WAS NO PATIENT CONSEQUENCE REPORTED AND PATIENT¿S OUTCOME WAS REPORTED TO BE FULLY RECOVERED. THERE WAS NO REPORT OF ANY ABLATION CATHETER IN THE PATIENT¿S BODY AT THE TIME OF THE ISSUE. THE CURRENT LEAKAGE ERROR WAS ASSESSED AS NOT MDR REPORTABLE AS THIS ISSUE IS HIGHLY DETECTABLE AND REQUIRES ADJUSTING SYSTEM COMPONENTS TO CONTINUE WITH THE PROCEDURE. DEVICES MAY REQUIRE RESET OR REPLACING BUT CANNOT BE USED ON THE PATIENT. ON FEBRUARY 7, 2020, THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND UPON INITIAL VISUAL INSPECTION, IT WAS NOTED THAT THE HEMOSTATIC VALVE AND FRICTION RING WERE DISLODGED INSIDE OF HUB. THE BRIM CAP REMAINED INTACT. THIS EVENT WAS ORIGINALLY CONSIDERED NOT MDR REPORTABLE, HOWEVER, BIOSENSE WEBSTER, INC. BECAME AWARE OF A REPORTABLE MALFUNCTION THROUGH ADDITIONAL ANALYSIS AND TESTING ON FEBRUARY 7, 2020 AND HAVE REASSESSED THIS COMPLAINT AS REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS FEBRUARY 7, 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258816 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 00001189 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1