BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15090485 · Received July 24, 2022

    Report

    Report Number
    2029046-2022-01687
    Event Type
    Malfunction
    Date Received
    July 24, 2022
    Date of Event
    June 29, 2022
    Report Date
    September 4, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 24-AUG-2022. THE DEVICE EVALUATION WAS COMPLETED ON 26-AUG-2022. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH-MEDIUM AND THE HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE HEMOSTATIC VALVE WAS TORN AND LEAKING FLUID WHEN THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM WAS BEING PREPPED. THE SHEATH LOOKED LIKE IT WAS CRACKED WHEN THEY INSPECTED IT AFTER THE PROCEDURE. WHEN THE SHEATH WAS REPLACED, THE ISSUE RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE PHYSICIAN REPORTED THAT SOMETHING FELT LIKE IT WAS STICKING NEAR THE VALVE AND DID NOT FEEL COMFORTABLE USING THE SHEATH. THE VALVE DID NOT BREAK INTO TWO OR MORE PIECES, BUT THE PHYSICIAN REPORTED IT LOOKED AS IF IT HAD A SMALL CRACK IN IT. THE VALVE DID NOT BECOME DETACHED. THE SHEATH WAS NOT USED ON THE PATIENT AS THE PHYSICIAN NOTICED THIS WHILE PREPPING THE SHEATH FOR USE AND DID NOT FEEL COMFORTABLE USING IT ON THE PATIENT. 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. HOWEVER, NO DAMAGE WAS OBSERVED ON THE DILATOR. A 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). 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 BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. 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-MEDIUM AND THE HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE HEMOSTATIC VALVE WAS TORN AND LEAKING FLUID WHEN THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM WAS BEING PREPPED. THE SHEATH LOOKED LIKE IT WAS CRACKED WHEN THEY INSPECTED IT AFTER THE PROCEDURE. WHEN THE SHEATH WAS REPLACED, THE ISSUE RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE PHYSICIAN REPORTED THAT SOMETHING FELT LIKE IT WAS STICKING NEAR THE VALVE AND DID NOT FEEL COMFORTABLE USING THE SHEATH. THE VALVE DID NOT BREAK INTO TWO OR MORE PIECES, BUT THE PHYSICIAN REPORTED IT LOOKED AS IF IT HAD A SMALL CRACK IN IT. THE VALVE DID NOT BECOME DETACHED. THE SHEATH WAS NOT USED ON THE PATIENT AS THE PHYSICIAN NOTICED THIS WHILE PREPPING THE SHEATH FOR USE AND DID NOT FEEL COMFORTABLE USING IT ON THE PATIENT. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A HEMOSTATIC VALVE SEPARATION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103191 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 50000156 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN BRAND SHEATH