BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19668332 · Received July 3, 2024

    Report

    Report Number
    2029046-2024-02244
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Date of Event
    January 1, 2024
    Report Date
    August 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS TO THE INITIAL REPORT: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. G1. MANUFACTURING SITE. IS FREUDENBERG MEDICAL LLC, THEREFORE G1 MANUFACTURING SITE DETAILS HAVE BEEN UPDATED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL, EXPERIENCED A HEMOSTATIC VALVE LEAK POST PROCEDURE. WHEN THE PHYSICIAN REMOVED THE CATHETER, THERE WAS BLOOD COMING OUT OF THE VALVE OF THE VIZIGO. IN ADDITION TO THAT, THE PHYSICIAN NOTICED AIR INSIDE THE VALVE. THE ISSUE OCCURRED AT THE HEMOSTATIC VALVE. THE VALVE DID NOT DISLODGE INSIDE OR OUTSIDE OF THE HUB. THE HUB DID NOT DETACH FROM THE SHEATH. THIS NECESSITATED SHEATH REPLACEMENT. THERE WERE NO PATIENT CONSEQUENCES. ADDITIONALLY, THE LOT NUMBER OF 00002568 HAS BEEN PROVIDED. THEREFORE, FIELDS D4. LOT, D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION EVALUATION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED TWO BENT MARKS IN THE SHAFT. AN IRRIGATION TEST WAS PERFORMED, AND WATER LEAKAGE WAS OBSERVED IN THE HANDLE AREA. FURTHER INVESTIGATION REVEALED THAT THE BENT MARKS OBSERVED IN THE SHAFT COULD HAVE DAMAGED THE INNER COMPONENTS CAUSING THE LEAKAGE. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE 00002568 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. SINCE THE SHAFT WAS FOUND WITH BENT MARKS, THIS FAILURE COULD BE RELATED TO THE HEMOSTATIC VALVE LEAK ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE DAMAGE IN THE SHAFT COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: DURING INSERTION, USE CAUTION NOT TO CREATE EXCESSIVE BENDS THAT MAY LEAD TO CRIMPS IN THIS DEVICE. AS PART OF BIOSENSE WEBSTER¿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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. 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 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL, EXPERIENCED A HEMOSTATIC VALVE LEAK POST PROCEDURE. WHEN THE PHYSICIAN REMOVED THE CATHETER, THERE WAS BLOOD COMING OUT OF THE VALVE OF THE VIZIGO. IN ADDITION TO THAT, THE PHYSICIAN NOTICED AIR INSIDE THE VALVE. THE ISSUE OCCURRED AT THE HEMOSTATIC VALVE. THE VALVE DID NOT DISLODGE INSIDE OR OUTSIDE OF THE HUB. THE HUB DID NOT DETACH FROM THE SHEATH. THIS NECESSITATED SHEATH REPLACEMENT. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281780 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00002568 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown