BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14849515 · Received June 29, 2022

    Report

    Report Number
    2029046-2022-01461
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Date of Event
    June 2, 2022
    Report Date
    August 18, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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

    THE DEVICE EVALUATION WAS COMPLETED ON 26-JUL-2022. IT WAS REPORTED THAT A 63-YEAR-OLD FEMALE PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. 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 DISLODGED INSIDE OF HUB COMPONENT. A 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 CAUSING THE DISLODGMENT OF THE VALVE; 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 (DHR) EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 00001738, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. BASED ON THE DHR, THE H4. DEVICE MANUFACTURE DATE HAS BEEN UPDATED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. 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 ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THIS ISSUE. 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 63-YEAR-OLD FEMALE PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE DOCTOR WAS USING THE MEDIUM VIZIGO¿ FOR AFIB ABLATION. THE DOCTOR NOTED FLUID WAS LEAKING FROM THE VIZIGO¿. UPON INSPECTION, THE VALVE HAD BEEN DAMAGED DURING PREPARATION AND WAS SEEN TO BE DISPLACED INTO THE CLEAR WINDOW. THE VIZIGO¿ WAS REPLACED, AND THE PREPARATION TEAM WAS TRAINED. THERE WAS NO PROCEDURE DELAY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES. THE VALVE WAS DISPLACED BY THE INTRODUCER. THE VALVE WAS PUSHED INTO THE SHEATH. THE HEMOSTASIS VALVE (GASKET) DID NOT BREAK INTO TWO OR MORE SEPARATE PIECES. IT IS UNKNOWN IF AIR ENTERED THE PATIENT¿S BODY. THIS ISSUE DID NOT REQUIRE PERCUTANEOUS OR SURGICAL REMOVAL. THE HEMODYNAMICS WERE NOT COMPROMISED DUE TO BLEEDING. THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS 5 ML. NO MEDICAL INTERVENTION WAS REQUIRED TO STOP BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910506 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 00001738 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female UNK BRAND SHEATH