BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 7121157 · Received December 15, 2017

    Report

    Report Number
    3013394970-2017-00610
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 12, 2017
    Report Date
    December 15, 2017
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION. ONE 8FR ANGIOSEAL STS PLUS DEVICE WAS RECEIVED FOR PRODUCT ANALYSIS AT TERUMO MEDICAL CORPORATION. THE DEVICE WAS RETURNED WITH THE POLYFOIL POUCH AND THE BYPASS TUBE. THE RETURNED COMPONENTS WERE SUBJECTED TO VISUAL ANALYSIS WHERE THE POLYFOIL POUCH WAS FOUND PARTIALLY OPEN. THE DEVICE CAP OF THE ANGIOSEAL STS PLUS DEVICE COULD BE SEEN PROTRUDING FROM THE PARTIALLY OPEN POLYFOIL POUCH AT AN ANGLE. THE BYPASS TUBE WAS RETURNED DETACHED FROM THE DISTAL TIP OF THE CARRIER TUBE ASSEMBLY AND OUTSIDE OF THE POLYFOIL POUCH. FOR FUNCTIONAL TESTING THE BYPASS TUBE WAS FITTED OVER THE DISTAL END OF THE CARRIER TUBE ASSEMBLY. THERE WERE NO ANOMALIES NOTED WHEN THIS WAS PERFORMED. ANGIOSEAL STS IFU STATE: "UNDER STRICT CONDITIONS AND USING STERILE FIELD, REMOVE THE ANGIOSEAL DEVICE CONTENTS FROM THE FOIL PACKAGE, TAKING CARE TO PULL FOIL APART COMPLETELY BEFORE REMOVING THE ANGIOSEAL DEVICE". 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.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS BEEN RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO FINDINGS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE PROTECTION SYSTEM WAS DELIVERED DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE USER FACILITY: NO PATIENT INVOLVEMENT, WAS PRE-TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900119 8F ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 5950784

    Patients

    Seq Age Sex Outcome Treatment
    1