BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 20194658 · Received September 11, 2024

    Report

    Report Number
    2029046-2024-03036
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 15, 2024
    Report Date
    October 4, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 12-SEP-2024. 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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO. DURING THE PROCEDURE, BLOOD LEAKAGE WAS FOUND IN HEMOSTATIC VALVE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE HEMOSTATIC VALVE DID NOT DISLODGE INSIDE THE HUB NOR OUTSIDE OF THE HUB. THE DEVICE EVALUATION WAS COMPLETED ON 18-SEP-2024. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER, INC. FOR EVALUATION. VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BIOSENSE WEBSTER, INC. PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS BROKEN IN THE STAR SECTION. 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 MANIPULATION WAS APPLIED. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE DAMAGE OBSERVED ON THE VALVE COULD CAUSE THE LEAK ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE DAMAGE COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH, DUE TO AN UNINTENDED USE ERROR; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. 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 BIOSENSE WEBSTER, INC.¿S 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 VIDEO WAS REVIEWED AND NO ROOT CAUSE CAN BE DETERMINED. HOWEVER, IT WAS REPORTED THAT THE DEVICE IS AVAILABLE FOR ANALYSIS. THEREFORE, ONCE THE DEVICE IS RECEIVED BY THE BWI PRODUCT ANALYSIS LAB, THE EVALUATION WILL BE PERFORMED. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO AND BLOOD LEAKAGE IN THE HEMOSTATIC VALVE ISSUE OCCURRED. DURING THE PROCEDURE, BLOOD LEAKAGE WAS FOUND IN HEMOSTATIC VALVE. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE HEMOSTATIC VALVE DID NOT DISLODGE INSIDE THE HUB NOR OUTSIDE OF THE HUB. THE BRIM CAP / HUB DID NOT BECOME DETACHED FROM THE SHEATH. THE SHEATH WAS BEING USED ON THE PATIENT. AIR DID NOT ENTER THE PATIENT¿S BODY. THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS 10ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474121 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000391 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown