BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14268120 · Received May 3, 2022

    Report

    Report Number
    2029046-2022-00926
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    February 8, 2022
    Report Date
    May 2, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE HEMOSTATIC VALVE WAS FOUND DISLODGED INSIDE THE HUB OF THE VIZIGO SHEATH. A DILATOR WAS INTRODUCED WITH THE HEMOSTATIC VALVE DISLODGED AND RESISTANCE WAS FOUND. THEN THE HEMOSTATIC VALVE WAS TAKEN OFF THE HUB AND THE DILATOR WAS INTRODUCED AGAIN AND NO RESISTANCE WAS FOUND. A MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED EVIDENCE OF DAMAGE TO THE OUTER DIAMETER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE FINISHED DEVICE 50000046 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. 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. 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

    A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE THE HUB OF THE VIZIGO SHEATH. THE FINDING WAS IDENTIFIED ON (B)(6) 2022. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DILATOR WOULD NOT FIT INTO THE SHEATH. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. OBSTRUCTED SHEATH IS NOT MDR-REPORTABLE. HEMOSTATIC VALVE SEPARATION IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500748 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 50000046 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown