BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14436445 · Received May 19, 2022

    Report

    Report Number
    2029046-2022-01051
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    February 1, 2022
    Report Date
    May 18, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 19-MAR-2022. THE DEVICE EVALUATION WAS COMPLETED ON 19-APR-2022. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. VISUAL AND DIMENSIONAL INSPECTIONS OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS NOT FOUND INSIDE THE DEVICE. THE HEMOSTATIC VALVE DETACHMENT COULD BE RELATED TO THE DILATOR WRONGLY INTRODUCED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE SHEATH AND THE DILATOR. THE DILATOR AND A GOOD KNOWN LAB SAMPLE CATHETER WERE INTRODUCED THROUGH THE SHEATH, AND NO OBSTRUCTION OR RESISTANCE WAS FELT. THE DILATOR'S OUTER DIAMETER WAS MEASURED, AND DIMENSIONS WERE FOUND WITHIN SPECIFICATIONS. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. LIKE THE HEMOSTATIC VALVE OBSTRUCTING THE DILATOR. 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. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE FINISHED DEVICE 00001885 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. 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 SUPRAVENTRICULAR TACHYCARDIA (SVT) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB INSPECTED THE DEVICE AND THE HEMOSTATIC VALVE WAS NOT FOUND IN THE HUB COMPONENT. INITIALLY, IT WAS REPORTED THAT THE DILATOR OF THE VIZIGO¿ SHEATH COULD NOT PASS THROUGH THE SHEATH. IT STOPPED BEING ABLE TO ADVANCE ABOUT HALFWAY THROUGH THE SHEATH. THE SHEATH WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS CONTINUED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE ISSUE OF OBSTRUCTED SHEATH WAS ASSESSED AS NOT MDR REPORTABLE. THERE IS EVIDENCE OF A PRODUCT MALFUNCTION, AS THE DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION OR OTHERWISE PERFORMED AS INTENDED, HOWEVER THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND OBSERVED THAT THE HEMOSTATIC VALVE WAS NOT FOUND IN THE HUB COMPONENT. THIS WAS ASSESSED AS A MDR REPORTABLE HEMOSTATIC VALVE SEPARATION PRODUCT MALFUNCTION. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 19-APR-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393482 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 00001885 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown