BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8482908 · Received April 4, 2019

    Report

    Report Number
    2029046-2019-02942
    Event Type
    Malfunction
    Date Received
    April 4, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 6, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 8, 2019 PROVIDING THE MANUFACTURER RECORD EVALUATION INFORMATION, INCLUDING THE MANUFACTURE DATE. THEREFORE, DEVICE MANUFACTURE DATE HAS BEEN POPULATED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 00001038 NUMBER, AND NO INTERNAL ACTIONS WAS FOUND DURING THE REVIEW. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON APRIL 23, 2019, IT WAS NOTED THAT ¿ MANUFACTURER ADDRESS STREET LINE . 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 "MANUFACTURER SITE ADDR. STREET LINE 1" HAVE BEEN RE-POPULATED. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND IT WAS REPORTED THAT WHEN INSERTING THE DILATOR, THE HOMEOSTATIC VALVE FOR THE SHEATH FAILED, "CRUMBLED APART". THE DEVICE WAS INSPECTED, AND THE BRIM CAP WAS OBSERVED CRACKED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON BRIM CAP AND HEMOSTATIC VALVE CANNOT BE DETERMINED, HOWEVER THIS COMPLAINT WILL BE ADDRESSED UNDER AN INTERNAL ACTION TO CONTINUE THE INVESTIGATION. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND IT WAS REPORTED THAT WHEN INSERTING THE DILATOR, THE HOMEOSTATIC VALVE FOR THE SHEATH FAILED, "CRUMBLED APART". THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THE ISSUE OF HEMOSTATIC VALVE ¿ SEPARATION IS CONSIDERED A REPORTABLE EVENT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON MARCH 22, 2019 AND IT WAS REPORTED THAT THE BRIM CAP WAS CRACKED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278785 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00001038 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1