BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 23044996 · Received September 12, 2025

    Report

    Report Number
    2029046-2025-03134
    Event Type
    Malfunction
    Date Received
    September 12, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 19, 2025
    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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO SHEATH AND OBSERVED BUBBLES IN THE STOPCOCK VALVE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 16-SEP-2025 OBSERVED THE HEMOSTATIC VALVE WAS BROKEN IN THE STAR SECTION. THE BWI PRODUCT ANALYSIS LAB BECAME AWARE OF THE HEMOSTATIC VALVE WAS BROKEN IN THE STAR SECTION ON (B)(6) 2025 AND HAVE ALSO ASSESSED THIS RETURNED CONDITION AS REPORTABLE. THE DEVICE EVALUATION WAS COMPLETED ON 16-SEP-2025. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J 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 FORE MANIPULATION WAS APPLIED. FINALLY, A BACK PRESSURE TEST WAS PERFORMED, AND A LEAKAGE WAS IDENTIFIED THROUGH THE HEMOSTATIC VALVE. IN ADDITION, BUBBLES WERE IDENTIFIED WHILE A NEGATIVE BACK PRESSURE TEST WAS PERFORMED. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE DAMAGE OBSERVED ON VALVE COULD CAUSE THE AIR 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 JOHNSON & JOHNSON MEDTECH'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 BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 09-SEP-2025. 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. 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 SHEATH AND OBSERVED BUBBLES IN THE STOPCOCK VALVE. THERE WERE A LOT OF BUBBLES IN THE STOPCOCK VALVE OF THE VIZIGO SHEATH. THE VIZIGO SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. NO AIR WAS INTRODUCED INTO THE PATIENT. THE PHYSICIAN DREW BLOOD OUT TO CLEAR BUBBLES AND IT DID NOT RESOLVE. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295361 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000661 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8.5 FR VARIPULSE CATHETER.| NGEN RF GENERATOR, US.| TRUPULSE GENERATOR, US.| UNK CATHETER CABLE.| UNK RF CABLE.| UNK_CARTO 3.