BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18419836 · Received December 29, 2023

    Report

    Report Number
    2029046-2023-03126
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    December 4, 2023
    Report Date
    February 13, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER PHONE : (B)(6). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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

    INITIALLY, IT WAS REPORTED THAT BLEEDING WAS OBSERVED ON THE SIDE PORT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE AND OBSERVED THAT THE HEMOSTATIC VALVE WAS BROKEN IN THE STAR SECTION. THE SIDE PORT LEAKAGE ISSUE REMAINS ASSESSED AS MDR REPORTABLE. THE ADDITIONAL FINDING OF THE BROKEN HEMOSTATIC VALVE IN THE STAR SECTION WAS ALSO ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE IS 22-JAN-2024. 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 BROKEN IN THE STAR SECTION. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. THE DAMAGE OBSERVED COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH. THE STRESS MARKS AND PHYSICAL DAMAGE OBSERVED SUGGEST THAT EXCESSIVE FORCE MANIPULATION WAS APPLIED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE FINISHED DEVICE 00002415 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE DAMAGE OBSERVED ON THE HEMOSTATIC VALVE COULD BE RELATED TO THE ISSUE REPORTED BY THE CUSTOMER. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) CONTAINS THE FOLLOWING CAUTION: ALWAYS INSERT A DILATOR STRAIGHT INTO THE CENTER OF THE SHEATH¿S VALVE TO PREVENT DAMAGE TO THE VALVE. DO NOT INSERT A DILATOR AT AN ANGLE, AS DAMAGE TO THE SHEATH VALVE MAY OCCUR. 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 A CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND REVERSE BLEEDING OCCURRED. IT WAS REPORTED THAT A SEPTAL PUNCTURE WAS PERFORMED WITH A RADIOFREQUENCY (RF) NEEDLE AND REVERSE BLEEDING WAS OBSERVED ON THE SIDE PORT (STOPCOCK/THREE-WAY VALVE) AFTER PUNCTURE. IT OCCURRED IMMEDIATELY AFTER SHEATH INSERTION. NO AIR ENTERED THE PATIENT¿S BODY. A FEW DROPS OF BLOOD WAS LOST (EXACT AMOUNT UNKNOWN). THE ISSUE WAS RESOLVED BY REPLACING THE VIZIGO¿ TO A NEW ONE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842240 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00002415 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN RF NEEDLE