BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8480231 · Received April 3, 2019

    Report

    Report Number
    2029046-2019-02928
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 5, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON APRIL 23, 2019, IT WAS NOTED THAT ¿. MANUFACTURER ADDRESS STREET LINE 1¿ . MANUFACTURER SITE ADDR. STREET LINE 1" ON THE 3500A INITIAL REPORT NEEDED CORRECTION. IT WAS INITIALLY SUBMITTED AS ¿31 TECHNOLOGY DRIVE¿. THE CORRECT ADDRESS IS ¿33 TECHNOLOGY DRIVE¿. THEREFORE, ¿MANUFACTURER ADDRESS STREET LINE 1¿ AND ". MANUFACTURER SITE ADDR. STREET LINE 1" HAVE BEEN RE-POPULATED. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 4/3/2019, IT WAS NOTICED THAT EXPIRATION DATE AND DEVICE MANUFACTURE DATE  FIELDS WERE INADVERTENTLY LEFT BLANK IN THE INITIAL 3500A SUBMITTED TO FDA. THE FIELDS HAVE NOW BEEN FILLED IN APPROPRIATELY. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND IT WAS DESCRIBED THAT DURING THE FLUSHING OF THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL, THE HEMOSTATIC VALVE TO AIR BUBBLES WERE FORMED IN THE HUB. THE DEVICE WAS INSPECTED, AND NO DAMAGE WAS OBSERVED. THE DEVICE WAS CONNECTED TO THE COOL FLOW PUMP AND NO BUBBLES OR ALARMS WERE OBSERVED DURING THE TEST, THE DEVICE WAS IRRIGATING CORRECTLY, AND NO WATER LEAKAGE WAS OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 00001068 NUMBER, AND NO INTERNAL ACTIONS WAS FOUND DURING THE REVIEW. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND IT WAS DESCRIBED THAT DURING THE FLUSHING OF THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL, THE HEMOSTATIC VALVE TO AIR BUBBLES WERE FORMED IN THE HUB. THIS ISSUE OCCURRED WHILE THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL WAS INSIDE THE PATIENT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE PRODUCT FOR EVALUATION ON MARCH 25, 2019, AND IT WAS NOTED THAT UPON INITIAL VISUAL INSPECTION, THERE WAS NO PHYSICAL DAMAGE IDENTIFIED. THE ISSUE OF AIR FLOWS BACK INTO THE SIDE PORT IS CONSIDERED A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271055 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00001068 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1