BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19324417 · Received May 15, 2024

    Report

    Report Number
    2029046-2024-01589
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    January 1, 2024
    Report Date
    June 12, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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

    ON 16-MAY-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THE HEMOSTATIC VALVE APPEARED TO BE LEAKING. THE PHYSICIAN STATED THAT THEY FAVOR USING THE VIZIGO SHEATH BUT DEFINITELY DETECTED 'SOMETHING WRONG WITH THE VALVE OF THE DEVICE'. THE PHYSICIAN COMPLAINED ABOUT A LITTLE BIT OF LEAKAGE AT THE HEMOSTATIC VALVE. FURTHERMORE, HE SAW A LITTLE BIT OF AIR ENTERING THE VALVE WHEN ASPIRATING, WHICH HE INTERPRETED AS A POSSIBLE LEAKAGE AT THE VALVE. HOWEVER, NO BLOOD RETURN WAS NOTED. NO PHYSICAL DAMAGE WAS IDENTIFIED EITHER. AFTER SWITCHING TO A NEW VIZIGO SHEATH, THE ISSUE WAS SOLVED. THE SURGICAL DELAY WAS APPROXIMATELY 3 MINUTES. THE PROCEDURE CONTINUED AND WAS SUCCESSFULLY COMPLETED. DEVICE EVALUATION DETAILS: THE PRODUCT 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 BROKEN IN THE STAR SECTION. A MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE DAMAGE. THE BROKEN CONDITION COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH; 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 NUMBER LOT 60000320 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE BROKEN HEMOSTATIC VALVE COULD BE RELATED TO THE AIR AND VALVE LEAKAGE REPORTED BY THE CUSTOMER THEREFORE, CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE STRESS MARKS OF THE HEMOSTATIC VALVE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: 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 DILATOR OR CATHETER RAPIDLY. DAMAGE TO HEMOSTATIC VALVE MAY OCCUR. FROM THE SIDEPORT ONLY, ASPIRATE ALL AIR PRIOR TO FLUID INFUSION; BEFORE INSERTING THE SHEATH INTO THE PATIENT, FLUSH THE SHEATH AND DILATOR WITH HEPARINIZED NORMAL SALINE TO REMOVE AIR BUBBLES AND ANY POTENTIAL PARTICULATE. 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. 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 ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THE HEMOSTATIC VALVE APPEARED TO BE LEAKING. THE PHYSICIAN STATED THAT THEY FAVOR USING THE VIZIGO SHEATH BUT DEFINITELY DETECTED 'SOMETHING WRONG WITH THE VALVE OF THE DEVICE'. THE PHYSICIAN COMPLAINED ABOUT A LITTLE BIT OF LEAKAGE AT THE HEMOSTATIC VALVE. FURTHERMORE, HE SAW A LITTLE BIT OF AIR ENTERING THE VALVE WHEN ASPIRATING, WHICH HE INTERPRETED AS A POSSIBLE LEAKAGE AT THE VALVE. HOWEVER, NO BLOOD RETURN WAS NOTED. NO PHYSICAL DAMAGE WAS IDENTIFIED EITHER. AFTER SWITCHING TO A NEW VIZIGO SHEATH, THE ISSUE WAS SOLVED. THE SURGICAL DELAY WAS APPROXIMATELY 3 MINUTES. THE PROCEDURE CONTINUED AND WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401207 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000320 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown