BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS

    MDR report key: 10137332 · Received June 10, 2020

    Report

    Report Number
    3013394970-2020-00308
    Event Type
    Malfunction
    Date Received
    June 10, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 10, 2020
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION OF THE ACTUAL DEVICE WAS UNABLE TO BE CONDUCTED. WITH NO RETURN OF THE ACTUAL DEVICE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO PROVIDE A CORRECTION. THE INCORRECT LOT NUMBER: 6100049 WAS INADVERTENTLY INITIALLY REPORTED IN SECTION D4. THEREFORE, SECTION D.4 LOT NUMBER HAS BEEN UPDATED TO REFLECT THE CORRECT LOT NUMBER: 06100049.

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. THE ACTUAL DEVICE HAS NOT 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 THAT THERE WAS A SMALL KINK OBSERVED ON THE ANGIO-SEAL DEVICE CARRIER TUBE, UPON FULLY OPENING THE ALUMINUM PACKAGE. THE DEVICE WAS PUT TO THE SIDE AND ANOTHER DEVICE WAS USED. A 7FR SHEATH WAS USED. THERE WERE NO DIFFICULTIES WITH ARTERIAL ACCESS, SHEATH, GUIDEWIRE, OR CATHETER INSERTION. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 20JUN2020. ANOTHER ANGIO-SEAL DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603479 8F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, OUS DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 06100049

    Patients

    Seq Age Sex Outcome Treatment
    1