BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8480236 · Received April 3, 2019

    Report

    Report Number
    2029046-2019-02929
    Event Type
    Malfunction
    Date Received
    April 3, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON APRIL 23, 2019, IT WAS NOTED THAT ¿MANUFACTURER ADDRESS STREET . 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 "G1 MANUFACTURER SITE ADDR. STREET LINE 1" HAVE BEEN RE-POPULATED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON APRIL 22, 2019 AND IT WAS DESCRIBED THAT THE BRIM CAP WAS CRACKED OPEN, THE HEMOSTATIC VALVE AND FRICTION RING WERE MISSING FROM THE HUB AND THE DISTAL END OF SHEATH WAS SLIGHTLY DAMAGED. THE ISSUE OF BRIM CAP AND HEMOSTATIC VALVE REMAIN REPORTABLE ISSUES. THE ISSUE OF THE DISTAL END OF THE SHEATH WAS ASSESSED AS NOT REPORTABLE AS THE INTEGRITY OF THE TIP IS MAINTAINED AND THERE WERE NO SHARP EDGES OR INTERNAL COMPONENTS EXPOSED.   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. 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 ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND IT WAS DESCRIBED THAT WHEN REMOVING THE DILATOR FROM THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM, THE HEMOSTATIC VALVE FELL OFF. THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. ON MARCH 22, 2019, ADDITIONAL INFORMATION AND PHOTOS WERE RECEIVED. AFTER REVIEW OF THE PHOTOS, IT WAS DETERMINED THAT THE BRIM CAP WAS ALSO DETACHED. IT WAS ALSO DESCRIBED THAT THE HEMOSTATIC VALVE BROKE OFF WHEN THE SHEATH WAS OUTSIDE OF THE PATIENT'S BODY, WHILE TAKING THE DILATOR OUT OF THE SHEATH ON THE PREPARATION TABLE, THEREFORE, THERE WAS NO BLEEDING THAT OCCURRED. THE PHYSICIAN STATED THAT ALTHOUGH THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM MALFUNCTION OCCURRED OUTSIDE THE PATIENT'S BODY, THE PATIENT'S ANATOMY WASN¿T STRAIGHT FORWARD EITHER. THERE WAS NO EXTENDED HOSPITALIZATION REQUIRED. THE DEVICE WAS INSPECTED, AND THE BRIM CAP WAS OBSERVED TO BE CRACKED AND OPEN. THE HEMOSTATIC VALVE AND FRICTION RING WERE MISSING FROM THE HUB AND THE DISTAL END WAS OBSERVED TO BE SLIGHTLY DAMAGED. 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 CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE ISSUE. THE ROOT CAUSE OF THE DAMAGE ON THE TIP COULD BE RELATED TO THE HANDLING OF THE DEVICE. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 00001070 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 ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND IT WAS DESCRIBED THAT WHEN REMOVING THE DILATOR FROM THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM, THE HEMOSTATIC VALVE FELL OFF. THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM WAS CHANGED OUT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. ON MARCH 22, 2019, ADDITIONAL INFORMATION AND PHOTOS WERE RECEIVED. AFTER REVIEW OF THE PHOTOS, IT WAS DETERMINED THAT THE BRIM CAP WAS ALSO DETACHED. IT WAS ALSO DESCRIBED THAT THE HEMOSTATIC VALVE BROKE OFF WHEN THE SHEATH WAS OUTSIDE OF THE PATIENT'S BODY, WHILE TAKING THE DILATOR OUT OF THE SHEATH ON THE PREPARATION TABLE, THEREFORE, THERE WAS NO BLEEDING THAT OCCURRED. THE PHYSICIAN STATED THAT ALTHOUGH THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM MALFUNCTION OCCURRED OUTSIDE THE PATIENT'S BODY, THE PATIENT'S ANATOMY WASN¿T STRAIGHT FORWARD EITHER. THERE WAS NO EXTENDED HOSPITALIZATION REQUIRED. THE ISSUE OF HEMOSTATIC VALVE ¿ SEPARATION AND THE BRIM CAP DETACHED ARE CONSIDERED REPORTABLE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271250 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00001070 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1