BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15810590 · Received November 16, 2022

    Report

    Report Number
    2029046-2022-02841
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 18, 2022
    Report Date
    December 23, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. 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).

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS COMPLETED ON 01-DEC-2022. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT WHEN THE DILATOR OF THE VIZIGO¿ SHEATH WAS REMOVED, THE HEMOSTATIC VALVE WAS BROKEN AND THERE WAS BLEED BACK FROM THE PATIENT. THE HEMOSTASIS VALVE (GASKET) DISLODGED INSIDE THE HUB BUT NOT OUTSIDE THE HUB. THE BRIM CAP/HUB DID NOT DETACH FROM THE SHEATH. THE SHEATH WAS USED ON THE PATIENT, INSERTED INTO THE SUPERIOR VENA CAVA (SVC). ONCE THE DILATOR WAS REMOVED, BLOOD WAS SEEN COMING BACK OUT OF THE SHEATH. AIR DID NOT ENTER THE PATIENT¿S BODY. THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS 10 CC. THE VIZIGO¿ SHEATH WAS EXCHANGED, AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED WITHOUT ANY FURTHER INCIDENT. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS:THE PRODUCT 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 THE HUB COMPONENT MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS AND A FISSURE ON IT. THE STRESS MARKS SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED DUE TO AN EXTREME OFF AXIS ANGLE OF INSERTION. THE VALVE WAS SENT TO SEM (SCANNING ELECTRON MICROSCOPE) FOR ANALYSIS AND THE RESULTS SHOW EVIDENCE OF MECHANICAL DAMAGE ON THE HEMOSTATIC VALVE. THESE DAMAGES COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE OR EXCESSIVE FORCE, DUE TO THE DAMAGES OBSERVED ON THE SURFACE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. NO OTHER ANOMALIES WERE OBSERVED. VALVE DISLODGEMENT OCCURS WHEN EXTREME OFF AXIS ANGLES ARE PERFORMED DURING INSERTION WITH THE DILATOR, OUTSIDE OF WHAT IS RECOMMENDED IN THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE).A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 60000002 AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW.THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ODP 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) IT WAS NOTED ON 23-DEC-2022, THAT THE B 5. EVENT DESCRIPTION ON THE INITIAL 3500A REPORT MWR-(B)(4) NEEDED CORRECTION. THE ISSUE REPORTED IS CONSIDERED TO BE A HEMOSTATIC VALVE SEPARATION, INSTEAD OF WHAT WAS PREVIOUSLY REPORTED AS ¿A HEMOSTATIC VALVE LEAK ISSUE¿ THE CORRECT H6. MEDICAL DEVICE PROBLEM CODE WAS SUBMITTED IN THE INITIAL 3500A REPORT. THEREFORE, NO CORRECTION IS NEEDED IN CODING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND A HEMOSTATIC VALVE LEAK ISSUE OCCURRED. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT WHEN THE DILATOR OF THE VIZIGO¿ SHEATH WAS REMOVED, THE HEMOSTATIC VALVE WAS BROKEN AND THERE WAS BLEED BACK FROM THE PATIENT. THE HEMOSTASIS VALVE (GASKET) DISLODGED INSIDE THE HUB BUT NOT OUTSIDE THE HUB. THE BRIM CAP/HUB DID NOT DETACH FROM THE SHEATH. THE SHEATH WAS USED ON THE PATIENT, INSERTED INTO THE SUPERIOR VENA CAVA (SVC). ONCE THE DILATOR WAS REMOVED, BLOOD WAS SEEN COMING BACK OUT OF THE SHEATH. AIR DID NOT ENTER THE PATIENT¿S BODY. THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS 10 CC. THE VIZIGO¿ SHEATH WAS EXCHANGED, AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED WITHOUT ANY FURTHER INCIDENT. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415977 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 60000002 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK BRAND SHEATH