BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19571383 · Received June 19, 2024

    Report

    Report Number
    2029046-2024-02028
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 23, 2024
    Report Date
    August 13, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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

    CORRECTIONS TO THE INITIAL REPORT: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. G1. MANUFACTURING SITE. IS FREUDENBERG MEDICAL LLC, THEREFORE G1 MANUFACTURING SITE DETAILS HAVE BEEN UPDATED. 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 VALVE OF THE VIZIGO¿ SHEATH DID NOT WORK PROPERLY CAUSING BLEED BACK. THE CASE CONTINUED WITHOUT REPLACING THE SHEATH. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION, EVALUATION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE WAS OBSERVED ON THE VIZIGO SHEATH. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE DID NOT SHOW STRESS MARKS ON THE OUTER DIAMETER. IN ADDITION, AN IRRIGATION TEST WAS PERFORMED AND NO LEAKAGE, AIR, NOR BUBBLES WERE OBSERVED. DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 00002558 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE HEMOSTATIC VALVE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: BEFORE INSERTING THE SHEATH INTO THE PATIENT, FLUSH THE SHEATH AND DILATOR WITH HEPARINIZED NORMAL SALINE TO REMOVE AIR BUBBLES AND ANY POTENTIAL PARTICULATE. AFTER THE SHEATH IS IN THE LEFT ATRIUM OF THE PATIENT, MAINTAIN A CONSTANT FLOW OF HEPARINIZED NORMAL SALINE TO THE SHEATH TO MINIMIZE THE RISK OF AIR EMBOLI. USE BEST PRACTICES FOR INSERTING OR RETRACTING ANY DEVICE AT THE HEMOSTATIC VALVE. MONITOR ANY POTENTIAL AIR ENTRAPPED AND COMPLETELY ASPIRATE ANY OBSERVED AIR OUT OF THE SIDE PORT. ONCE THE SHEATH IS INSERTED INTO THE VASCULATURE AND THE DILATOR IS REMOVED, ASPIRATE UNTIL STEADY BLOOD RETURN IS ACHIEVED PRIOR TO FLUSHING OR INFUSION. ALL FLUID INFUSION SHOULD BE THROUGH THE SIDE PORT. IN ORDER TO MINIMIZE THE RISK OF AIR EMBOLISM PROVIDE A CONTINUOUS INFUSION OF HEPARINIZED SALINE SOLUTION ONCE THE SHEATH IS INSERTED INTO THE PATIENT. SLOWLY REMOVE OR INSERT THE DILATOR OR OTHER DEVICES. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (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 VALVE OF THE VIZIGO¿ SHEATH DID NOT WORK PROPERLY CAUSING BLEED BACK. THE CASE CONTINUED WITHOUT REPLACING THE SHEATH. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654707 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00002558 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown