BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8476323 · Received April 2, 2019

    Report

    Report Number
    2029046-2019-02925
    Event Type
    Malfunction
    Date Received
    April 2, 2019
    Date of Event
    March 5, 2019
    Report Date
    March 5, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON (B)(6)2019 , IT WAS NOTED THAT ¿D3. MANUFACTURER ADDRESS STREET LINE 1¿ AND "G1. 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, ¿D3. MANUFACTURER ADDRESS STREET LINE 1¿ AND "G1. MANUFACTURER SITE ADDR. STREET LINE 1" HAVE BEEN RE-POPULATED. ALSO, AS PART OF THE INTERNAL REVIEW, A CORRECTION TO B5. EVENT DESCRIPTION, IT WAS REPORTED THE THE BRIM CAP AND HEMOSTATIC VALVE WERE BROKEN, HOWEVER, IT WAS DETERMINED THAT BOTH THE BRIM CAP AND THE HEMOSTATIC VALVE WERE BROKEN OFF. THE ASSESSMENT OF THE BRIM CAP REMAINS ASSESSED AS A REPORTABLE EVENT AND THE THE ISSUE OF THE HEMOSTATIC VALVE WAS ALSO ASSESSED A REPORTABLE EVENT. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND IT WAS DESCRIBED THAT THE ORANGE HUB ON THE VIZIGO SHEATH BROKE DURING THE SHEATH PREP. IT WAS REPORTED THAT THE PRODUCT WAS RETURNED WITH THE BRIM CAP AND HOMEOSTATIC VALVE BROKEN. THE DEVICE WAS INSPECTED AND THE BRIM CAP AND HEMOSTATIC VALVE WERE BROKEN OFF. 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, AN INTERNAL ACTION WAS CREATED TO INVESTIGATE THIS ISSUE. 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 00001056 NUMBER, AND NO NON-CONFORMANCES WERE GENERATED DURING THE DEVICE MANUFACTURING. MANUFACTURER'S REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND IT WAS DESCRIBED THAT THE ORANGE HUB ON THE VIZIGO SHEATH BROKE DURING THE SHEATH PREP. 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 BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE PRODUCT ON APRIL 2, 2019, AND IT WAS REPORTED THAT THE PRODUCT WAS RETURNED WITH THE BRIM CAP AND HOMEOSTATIC VALVE BROKEN. THE ISSUE OF THE BRIM CAP DETACHED IS CONSIDERED A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266159 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00001056 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1