BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US

    MDR report key: 6991625 · Received October 31, 2017

    Report

    Report Number
    2243441-2017-00183
    Event Type
    Malfunction
    Date Received
    October 31, 2017
    Date of Event
    October 4, 2017
    Report Date
    October 31, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE UNUSED 8F ANGIOSEAL EVOLUTION WAS RETURNED FOR EVALUATION TO TERUMO MEDICAL CORPORATION IN (B)(4).THE PACKAGING WAS INTACT NO DAMAGE OR DEFORMATION WAS OBSERVED EXTERNALLY. THE PLASTIC POUCH WAS OPENED AND THE HEMOSTASIS TUBE WAS CHECKED FOR MANEUVERABILITY USING DIGITAL PRESSURE.THE SHEATH TUBING HELD ITS MATERIAL INTEGRITY AND KINKED UPON APPLICATION OF HIGH PRESSURE BUT DID NOT CRACK. NO OTHER VISUAL ANOMALIES WERE NOTED. THE COMPLAINT FOR CRACKED SHEATH CANNOT BE CONFIRMED, THE DEVICE WAS NOT DAMAGED IN ANY WAY UPON RECEIPT AND DID NOT EXHIBIT ANY BRITTLENESS UPON EXAMINATION.THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH TERUMO MEDICAL CORPORATION SPECIFICATIONS AND PROCEDURES. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. A SEARCH OF THE COMPLAINT FILE DIDN'T FIND ANY OTHER REPORTS WITH THE INVOLVED PRODUCT CODE/LOT# COMBINATION. THE USER FACILITY REPORTED SIMILAR EVENTS. SEE MDRS 2243441-2017- 00179, 2243441-2017-00180, 2243441-2017-00181, 2243441-2017-00182, AND 2243441-2017-00184. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE SHEATH WAS FRACTURED IN PACKAGING BEFORE BEING OPENED OR INTRODUCED TO THE PATIENT. IT WAS REPORTED THAT THIS OCCURRED PRE-TREATMENT AND NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771055 8F ANGIO-SEAL EVOLUTION VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION NA 5904971

    Patients

    Seq Age Sex Outcome Treatment
    1