BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    MDR report key: 10311968 · Received July 22, 2020

    Report

    Report Number
    2029046-2020-00918
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Date of Event
    June 23, 2020
    Report Date
    June 23, 2020
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION DETAILS: THE DEVICE EVALUATION HAS BEEN COMPLETED. THE DEVICE WAS INSPECTED, AND IT WAS FOUND IN GOOD NORMAL CONDITIONS, THE DILATOR WAS NOT RETURNED, THE HEMOSTATIC VALVE LOOKS IN GOOD NORMAL CONDITIONS TOO; HOWEVER, WAS FOUND REDDISH-BROWN MATERIAL ON IT. THEN, FLOW TEST WAS PERFORMED WITH A SYRINGE CONNECTED TO THE VALVE TO INTRODUCE WATER THROUGH THE SHEATH AND THERE WERE NOT ISSUES OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE DEVICE PASSED THE TEST. THE ROOT CAUSE OF THE MALFUNCTION EVENT REMAINS UNKNOWN. THE CATHETER PASS SPECIFICATION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER¿S REF # (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 - MEDIUM AND A HEMOSTATIC VALVE DYSFUNCTION OCCURRED ALONG WITH AIR BACKFLOWING FROM THE SIDE PORT. IT WAS REPORTED THAT WHILE THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM WAS USED ON THE PATIENT THERE WAS AIR COMING BACK WHEN PULLING BACK THE SHEATH, AND THERE WAS ALSO BLOOD LEAKING BACK FROM THE HEMOSTATIC VALVE. THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE CARTO 3 SYSTEM IS OPERATING PER SPECS AND IS NOT RESPONSIBLE FOR THE PRODUCT ISSUE. THE SHEATH HAS BEEN DETERMINED TO BE THE ROOT CAUSE OF THE COMPLAINT REPORTED. THE PROCEDURE WAS CONTINUED. THERE WAS NO REPORT OF PATIENT CONSEQUENCE NOR EXTENDED HOSPITALIZATION. THE PHYSICIAN¿S CASUALTY OPINION WAS NOT PROVIDED. ON 6/24/2020, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL EVENT INFORMATION. IT WAS THAT THE HEMOSTATIC VALVE BROKE/SEPARATED. IT DID NOT DETACH FROM THE SHEATH. IT WAS IN ONE PIECE BUT WOULD NOT RESET WITH THE DILATOR. NO AIR ENTERED THE BODY AND NO MEDICAL INTERVENTION WAS REQUIRED. THERE WAS NO HEMODYNAMIC INSTABILITY, 5CC OF BLOOD WAS LOST. THERE WAS NO INTERVENTION TO STOP THE BLEEDING. ON 6/29/2020, THE COMPLAINT PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC.¿S (BWI) PRODUCT ANALYSIS LAB (PAL) FOR EVALUATION. INITIAL VISUAL INSPECTION FOUND NO VISUAL DAMAGE OR ANOMALIES. THE DILATOR WAS NOT RETURNED. THESE FINDINGS WERE ASSESSED AS NOT MDR REPORTABLE, HOWEVER, THE COMPLAINT REMAINS REPORTABLE PER EVENT DESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775789 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC. D138502 00001292 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1