BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US

    MDR report key: 8784810 · Received July 12, 2019

    Report

    Report Number
    3013394970-2019-00524
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Date of Event
    June 25, 2019
    Report Date
    July 12, 2019
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    UDI-DI
    00038901011820
    PMA / PMN Number
    P930038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 TO UPDATE DEVICE EVALUATED BY MFR, AND TO PROVIDE THE COMPLETED INVESTIGATION RESULTS. ONE 6FR ANGIO-SEAL VIP DEVICE WAS RETURNED FOR EVALUATION. THE ARTERIOTOMY LOCATOR, HEMOSTASIS SHEATH AND THE HEADER BAG WERE RETURNED. THE CARRIER TUBE ASSEMBLY WAS RETURNED ALONG WITH THE INCOMPLETELY OPENED POLY FOIL POUCH AS WELL. VISUAL INSPECTION REVEALED THAT THERE WAS A DEFORMATION IDENTIFIED AT THE BLOOD INLET HOLE OF THE ARTERIOTOMY LOCATOR. THE LOCATOR WAS SEVERELY KINKED. NO DAMAGE OR DEFORMATION WAS NOTED WITH THE RETURNED SHEATH. THE INCOMPLETELY OPENED POLY-FOIL POUCH WAS ATTEMPTED TO BE COMPLETELY OPENED AND THE CARRIER TUBE ASSEMBLY WAS CAREFULLY REMOVED FROM IT. THE BYPASS TUBE WAS FOUND PROTECTING THE ANCHOR OF THE CARRIER TUBE ASSEMBLY. NO OTHER VISUAL ANOMALIES WERE NOTED WITH THE RETURNED COMPONENTS. BASED ON THE PROVIDED INFORMATION AND INVESTIGATION RESULTS, THERE IS NO DEFINITIVE EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. BASED ON THE INVESTIGATION RESULTS IT IS LIKELY THAT OFF-AXIS FORCE TO THE ARTERIOTOMY LOCATOR MAY HAVE CAUSED THE KINKING. THE EXTREME ANGLE OF KINK SUGGESTS THAT THE DEFORMATION OCCURRED AFTER REMOVAL FROM THE PACKAGE. HOWEVER, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION.

    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 WHEN THEY OPENED THE ANGIO-SEAL, THE DILATOR WAS BENT AND NOT ABLE TO BE USED. ANOTHER ANGIO-SEAL DEVICE WAS OPENED, AND IT WAS OK. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THERE WERE NO OTHER DEVICES OR EQUIPMENT BEING USED WITH HE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 09, 2019. THE PROCEDURE BEING PERFORMED PRIOR TO THE USE OF THE ANGIO-SEAL WAS A LEFT HEART CATHETERIZATION USING A 6FR SHEATH. A PRE-DEPLOYMENT ANGIOGRAM WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577673 6F ANGIO-SEAL VIP VASCULAR CLOSURE DEVICE, US DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A 06092814 00038901011820

    Patients

    Seq Age Sex Outcome Treatment
    1