BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15393867 · Received September 9, 2022

    Report

    Report Number
    2029046-2022-02173
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 19, 2022
    Report Date
    November 9, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016260
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS COMPLETED ON 18-OCT-2022. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. IT WAS REPORTED THAT THE HEMOSTATIC VALVE BECAME DISLODGED AND THERE WAS BLEED BACK FROM THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE. THEY REPLACED THE SHEATH AND THE ISSUE WAS RESOLVED. THE CASE WAS CONTINUED WITHOUT ANY FURTHER INCIDENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE THE HUB COMPONENT. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. THE STRESS MARKS SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED DUE TO AN EXTREME OFF AXIS ANGLE OF INSERTION. VALVE DISLODGEMENT OCCURS WHEN EXTREME OFF AXIS ANGLES ARE PERFORMED DURING INSERTION WITH THE DILATOR, OUTSIDE OF WHAT IS RECOMMENDED IN THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE). STRESS MARKS WERE ALSO OBSERVED ON THE LUER HUB AND IN THE CAP, AND THE SILICON PRESENTED TEAR-LIKE DAMAGES. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ODP CONTAINS THE FOLLOWING CAUTION: ALWAYS INSERT A DILATOR STRAIGHT INTO THE CENTER OF THE SHEATH¿S VALVE TO PREVENT DAMAGE TO THE VALVE. DO NOT INSERT A DILATOR AT AN ANGLE, AS DAMAGE TO THE SHEATH VALVE MAY OCCUR. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION 07-OCT-2022. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. IT WAS REPORTED THAT THE HEMOSTATIC VALVE BECAME DISLODGED AND THERE WAS BLEED BACK FROM THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE. THEY REPLACED THE SHEATH AND THE ISSUE WAS RESOLVED. THE CASE WAS CONTINUED WITHOUT ANY FURTHER INCIDENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. IT DISLOCATED INSIDE THE CLEAR PORT. THE ISSUE DID NOT REQUIRE PERCUTANEOUS, SURGICAL REMOVAL OR MEDICAL INTERVENTION. THE CASE WAS NOT A CARTO CASE. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A HEMOSTATIC VALVE SEPARATION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215736 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138503 00002016 10846835016260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN BRAND SHEATH