BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH -

    MDR report key: 8519979 · Received April 16, 2019

    Report

    Report Number
    2029046-2019-02995
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    March 21, 2019
    Report Date
    March 21, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH, AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE INVESTIGATIONAL ANALYSIS COMPLETED ON 5/8/2019. THE DEVICE WAS INSPECTED AND NO ISSUES WERE OBSERVED. DURING A SECOND VISUAL INSPECTION, THE HEMOSTATIC VALVE WAS FOUND COLLAPSED INSIDE THE HUB. ADDITIONALLY, SCANNING ELECTRON MICROSCOPE (SEM) TESTING WAS PERFORMED ON THE DAMAGED AREA AND THE RESULTS SHOWED EVIDENCE OF MECHANICAL DAMAGE ON THE SURFACE OF THE HEMOSTATIC VALVE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED AND NO INTERNAL ACTIONS WERE IDENTIFIED.  THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE DAMAGE ON THE VALVE CANNOT BE RELATED TO THE MANUFACTURING PROCESS SINCE THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. IT COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. MANUFACTURE REF NO: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH, AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. IN THE INITIAL REPORT, THE MANUFACTURE ADDRESS WAS ERRONEOUSLY REPORTED AS 31 TECHNOLOGY DR. IRVINE, CA 92618. THE CORRECT ADDRESS IS 33 TECHNOLOGY DR. IRVINE, CA 92618. ON 4/25/2019, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS WERE FOUND DURING THE REVIEW. 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. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED THE DEVICE FOR EVALUATION ON 4/3/2019, AND UPON INITIAL INSPECTION NO ANOMALIES OR DAMAGES WERE OBSERVED. DURING A SECOND VISUAL INSPECTION ON 4/3/2019, THE BWI PAL FOUND THE HEMOSTATIC VALVE COLLAPSED INSIDE OF HUB. THESE FINDING COINCIDE WITH WHAT WAS ORIGINALLY REPORTED. 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. MANUFACTURE REFERENCE NO: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH, AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. WHEN THE DILATOR WAS INSERTED INTO THE HEMOSTATIC VALVE, THE VALVE RUPTURED RESULTING IN BLEED BACK THROUGH THE VALVE. THE PHYSICIAN CHANGED TO A COMPETITOR¿S SHEATH AS ANOTHER VIZIGO WAS NOT AVAILABLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE OBSERVED HEMOSTATIC VALVE SEPARATION ISSUE HAS BEEN ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310669 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00001064 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1