BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE

    MDR report key: 9563365 · Received January 8, 2020

    Report

    Report Number
    3013394970-2019-01064
    Event Type
    Injury
    Date Received
    January 8, 2020
    Report Date
    January 8, 2020
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    MGB
    PMA / PMN Number
    P930038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    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 · 1

    EXPIRATION DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. UDI: UNKNOWN DUE TO UNKNOWN LOT NUMBER. IMPLANTED DATE: UNKNOWN DUE TO UNKNOWN DATE OF EVENT. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE: UNKNOWN DUE TO UNKNOWN LOT NUMBER. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD.

    Description of Event or Problem · 1

    PER LITERATURE REVIEW: THE ARTICLE ENTITLED, AN UPDATE ON THE USE OF AN ARTERIAL CLOSURE DEVICE FOLLOWING FEMORAL ARTERIAL PUNCTURE IN CHILDREN. PEDIATRIC RADIOLOGY (2019) 49:1217-1221. (B)(6)-YEAR-OLD PATIENT WITH VESSEL SIZE OF 8X8 MM, EXPERIENCED TRANSIENT PERIPHERAL PULSE LOSS AFTER DEPLOYMENT. ULTRASOUND AFTER DIMINISHED PULSES DEMONSTRATED PATENCY OF THE EXTERNAL ILIAC ARTERY AND ARTERIES DISTAL TO THE COMMON FEMORAL ARTERY. THE COMMON FEMORAL ARTERY WAS POORLY EVALUATED DUE TO REPORTED GAS ARTIFACT FROM THE ARTERIAL ACCESS AND THE CLOSURE DEVICE. THUS, IT WAS NOT CLEAR IF THROMBUS OR SPASM WAS PRESENT. PATIENT WAS ON ANTICOAGULATION, SO NO ADDITIONAL INTERVENTION WAS PERFORMED ASIDE FROM ADDITIONAL NURSING MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28700 UNK 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB TERUMO MEDICAL CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other| R