BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 21142503 · Received January 13, 2025

    Report

    Report Number
    2029046-2025-00150
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 16, 2024
    Report Date
    February 10, 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 CARE PROFESSIONAL
    Health Professional
    Yes

    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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR RECIPROCATING TACHYCARDIA (AVRT) /WOLFF-PARKINSON-WHITE (WPW) ABLATION PROCEDURE WITH A VIZIGO. WHEN THE DOCTOR HAD THE SHEATH IN THE BODY, THE SHEATH WAS PULLING AIR. AS THE PHYSICIAN WAS ASPIRATING THE VIZIGO SHEATH, A LOT OF AIR WAS BEING PULLED FROM THE SYSTEM. THE LEADING THOUGHT WAS THAT THE AIR WAS COMING FROM THE PROXIMAL, HEMOSTATIC VALVE THAT CATHETERS AND DILATORS ENTER THROUGH. THE PHYSICIAN WAS ATTEMPTING TO REMOVE ALL AIR FROM THE VIZIGO SYSTEM. HE WAS TRANSEPTAL ALREADY, IN THE LEFT ATRIUM, AND WAS USING A SALINE FLUSH TO ASPIRATE THE SYSTEM BEFORE CATHETER INTRODUCTION. IT WAS AT THIS TIME HE NOTICED EXCESS AIR BEING PULLED THROUGH THE SYSTEM. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE SHEATH WAS REPLACED WITH NO RESOLUTION. WHEN THE SHEATH WAS REPLACED WITH A NON-J&J SHEATH, THE ISSUE WAS RESOLVED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE INVESTIGATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. VISUAL AND MICROSCOPICAL INSPECTION AND BACKPRESSURE TEST OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH J&J MEDTECH PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE OR ANOMALIES WERE OBSERVED ON THE VIZIGO SHEATH. BACK PRESSURE TEST WAS PERFORMED, AND AIR BUBBLES WERE OBSERVED COMING THROUGH THE HEMOSTATIC VALVE. A MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS AND DAMAGE. THIS 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 RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 60000537 AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. 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. PER INTERNAL REVIEW ON 5-FEB-2025, THE H6 MEDICAL DEVICE PROBLEM CODE OF "BACKFLOW" (A140501) NO LONGER APPLIES. IT WAS DETERMINED THAT THE CODE OF "FLUID LEAK" (A050401) IS THE MOST APPLICABLE TO THIS EVENT. AS A RESULT, THE H6 MEDICAL DEVICE PROBLEM CODE WAS UPDATED ACCORDINGLY IN THIS SUPPLEMENTAL REPORT. 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 ATRIOVENTRICULAR RECIPROCATING TACHYCARDIA (AVRT) /WOLFF-PARKINSON-WHITE (WPW) ABLATION PROCEDURE WITH A VIZIGO. WHEN THE DOCTOR HAD THE SHEATH IN THE BODY, THE SHEATH WAS PULLING AIR. AS THE PHYSICIAN WAS ASPIRATING THE VIZIGO SHEATH, A LOT OF AIR WAS BEING PULLED FROM THE SYSTEM. THE LEADING THOUGHT WAS THAT THE AIR WAS COMING FROM THE PROXIMAL, HEMOSTATIC VALVE THAT CATHETERS AND DILATORS ENTER THROUGH. THE PHYSICIAN WAS ATTEMPTING TO REMOVE ALL AIR FROM THE VIZIGO SYSTEM. HE WAS TRANSEPTAL ALREADY, IN THE LEFT ATRIUM, AND WAS USING A SALINE FLUSH TO ASPIRATE THE SYSTEM BEFORE CATHETER INTRODUCTION. IT WAS AT THIS TIME HE NOTICED EXCESS AIR BEING PULLED THROUGH THE SYSTEM. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE SHEATH WAS REPLACED WITH NO RESOLUTION. WHEN THE SHEATH WAS REPLACED WITH A NON-J&J SHEATH, THE ISSUE WAS RESOLVED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425941 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000537 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown 8.5F SHEATH WITH CURVE VIZ MDC| BAYLIS NRG C1| NGEN GENERATOR