BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8.5F SHEATH WITH CURVE VIZ MDC

    MDR report key: 8494002 · Received April 8, 2019

    Report

    Report Number
    2029046-2019-02960
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 15, 2019
    Report Date
    March 15, 2019
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE INVESTIGATIONAL ANALYSIS COMPLETED (B)(6) 2019. THE DEVICE WAS INSPECTED AND THE HUB CAP, VALVE, AND SILICONE RING WERE FOUND DETACHED FROM THE HUB. 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 HUB CAP CANNOT BE DETERMINED. HOWEVER, AN INTERNAL CORRECTIVE ACTION WAS CREATED TO INVESTIGATE THIS ISSUE. MANUFACTURER REFERENCE NO:(B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION 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 4/12/2019, A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE AND NO INTERNAL ACTIONS WERE FOUND DURING THE REVIEW. ADDITIONALLY THE EXPIRATION DATE OF: AND MANUFACTURE DATE OF: WERE PROVIDED. MANUFACTURE REFERENCE NO: (B)(4).

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW, A CORRECTION IS BEING MADE TO THE INVESTIGATION SUMMARY AS IT WAS NOT PART OF AN INTERNAL CORRECTIVE ACTION. MANUFACTURE REFERENCE NO: PC-000415906.

    Additional Manufacturer Narrative · 1

    THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2019, AND FOUND THE BRIM CAP SEPARATED FROM THE VALVE. THESE FINDINGS COINCIDE WITH WHAT IS BEING REPORTED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE HEMOSTATIC VALVE BROKE OFF THE VIZIGO SHEATH. THE SHEATH WAS CHANGED AND THE ISSUE RESOLVED. WHEN THE DILATOR WAS REMOVED, AFTER THE SHEATH WAS PLACED IN THE BODY, THE VALVE CAME OFF WITH THE DILATOR. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE HEMOSTATIC VALVE SEPARATION ISSUE HAS BEEN ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286683 8.5F SHEATH WITH CURVE VIZ MDC INTRODUCER, CATHETER LPB BIOSENSE WEBSTER INC 00001038 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1