BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL

    MDR report key: 10818212 · Received November 10, 2020

    Report

    Report Number
    2029046-2020-01660
    Event Type
    Malfunction
    Date Received
    November 10, 2020
    Date of Event
    October 13, 2020
    Report Date
    October 13, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION SUMMARY WAS COMPLETED ON 12/11/2020. IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL WHERE HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE VALVE WAS MALFUNCTIONING WHEN THE SMART TOUCH CATHETER WAS INSERTED. THE ISSUE WAS RESOLVED BY CHANGING THE SHEATH TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE SHEATH WAS INSPECTED AND VISUAL ANALYSIS REVEALED THAT HEMOSTATIC VALVE APPEARS DISLODGED INSIDE OF THE HUB. BRIM CAP AND FRICTION RING REMAINED INTACT. IT WAS DETERMINED THAT THE ISSUE OBSERVED COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT. ODP (OPTIMAL PERFORMANCE GUIDE), THERE ARE SOME PRECAUTIONS ON INSERTING THE DILATOR INTO THE VIZIGO SHEATH. ACCORDING TO THE ODP (OPTIMAL PERFORMANCE GUIDE), THERE ARE SOME PRECAUTIONS ON INSERTING THE DILATOR INTO THE VIZIGO SHEATH. - 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. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON THE HEMOSTATIC VALVE INSIDE THE HUB COULD BE RELATED WITH THE EXCESSIVE FORCE AND HANDLING OF THE SHEATH DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) PROVIDES ADDITIONAL INSTRUCTIONS ON HOW TO INSERT THE DILATOR INTO THE SHEATH. IN ADDITION, THERE IS EVIDENCE THAT THE SHEATH WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

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

    IT WAS REPORTED THAT A PATIENT UNDERWENT CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL WHERE HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE VALVE WAS MALFUNCTIONING WHEN THE SMART TOUCH CATHETER WAS INSERTED. THE ISSUE WAS RESOLVED BY CHANGING THE SHEATH TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE ISSUE WAS ASSESSED AS AN MDR REPORTABLE HEMOSTATIC VALVE SEPARATION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285199 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00001393

    Patients

    Seq Age Sex Outcome Treatment
    1 SMART TOUCH CATHETER.| UNKNOWN BRAND SHEATH.