BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO¿ SHEATH

    MDR report key: 19710408 · Received July 10, 2024

    Report

    Report Number
    2029046-2024-02303
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 19, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 23-JUL-2024, BWI RECEIVED THE MANUFACTURE DATE FOR THE DEVICE (9-JAN-2024 IS THE MANUFACTURE DATE). D4 PRIMARY UDI NUMBER HAS BEEN UPDATED TO (B)(4). BWI ALSO NOTED UPDATES TO THE 3500A INITIAL AS THE 1. MANUFACTURING SITE NAME WAS PROCESSED UNDER BIOSENSE WEBSTER INC (IRVINE) AND HAS BEEN PROCESSED AS FREUDENBERG MEDICAL LLC. UPDATED G1. MANUFACTURING SITE NAME. IN ADDITION, UPDATED G1. MANUFACTURER SITE ADDR. STREET LINE 1, G1. MANUFACTURER SITE CITY, G1. MANUFACTURER SITE STATE CODE AND G1. MANUFACTURER SITE ZIP CODE AND G1. MANUFACTURER SITE COUNTRY CODE. ADDITIONALLY, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION ON 16-AUG-2024. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A VIZIGO¿ SHEATH AND THE SHEATH HAD A WHITE OBJECT LOOSE OR FLOATING INSIDE THE HEMOSTATIC VALVE AND TRANSPARENT HUB. THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF THE HUB. IN ADDITION, THERE WAS TRACE AMOUNTS OF BLOOD BACKING UP AND LEAKING IN THE VALVE. BLOOD AND AIR WAS BEING ASPIRATED BY THE OPERATOR. THE VIZIGO¿ SHEATH WAS REPLACED AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) 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 OF HUB COMPONENT. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. THE STRESS MARKS AND PHYSICAL DAMAGE OBSERVED SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE FINISHED DEVICE 60000348 NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE WHITE OBJECT REPORTED BY THE CUSTOMER COULD BE RELATED TO THE DISLODGMENT OF THE VALVE ISSUE IDENTIFIED DURING THE ANALYSIS; THEREFORE, THE COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSED OF THE DAMAGE ON THE VALVE COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT OF THE VALVE. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING PRECAUTIONS: 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. DO NOT REMOVE THE DILATOR OR CATHETER RAPIDLY. DAMAGE TO THE HEMOSTATIC VALVE MAY OCCUR. 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. 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 REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. 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 REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A VIZIGO¿ SHEATH AND THE SHEATH HAD A WHITE OBJECT LOOSE OR FLOATING INSIDE THE HEMOSTATIC VALVE AND TRANSPARENT HUB. THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF THE HUB. IN ADDITION, THERE WAS TRACE AMOUNTS OF BLOOD BACKING UP AND LEAKING IN THE VALVE. BLOOD AND AIR WAS BEING ASPIRATED BY THE OPERATOR. THE VIZIGO¿ SHEATH WAS REPLACED AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977487 VIZIGO¿ SHEATH INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000341 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN RF GENERATOR, US