BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 8631059 · Received May 22, 2019

    Report

    Report Number
    3009984513-2019-00001
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    December 14, 2017
    Report Date
    May 22, 2019
    Manufacturer
    VASORUM LTD
    Product Code
    MGB
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE PROCESSING OF THIS COMPLAINT ALL ATTEMPTS WERE MADE TO OBATAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. VASORUM LTD IS SUBMITTING THIS REPORT ON BEHALF OF DJ MEDICAL CONSULTING & DISTRIBUTION LLC, IN ACCORDANCE WITH THE CONDITIONS OUTLINED WITH THE MDR EXEMPTION E2017048. VASORUM LTD TRINITAS HOUSE 2012 ORCHARD AVENUE CITYWEST BUSINESS PARK D24 WPW6 DUBLIN - IRELAND DJ MEDICAL CONSULTING AND DISTRIBUTION LLC 20 RYANS LANE DUXBURY MA 02332 USA

    Description of Event or Problem · 0

    DEVICE WAS DEPLOYED IN A 6F SHEATH AT THE END OF A PERIPHERAL INTERVENTION PROCEDURE IN THE RIGHT COMMON FEMORAL ARTERY. AFTER STEP 3, PHYSICIAN NOTED BLEEDING. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. PHYSICIAN USED FLUOROSCOPY TO LOCATE THE IMPLANT IN THE RIGHT SFA. THERE WERE NO SIGNS OF VESSEL STENOSIS OR LEG ISCHEMIA. PHYSICIAN DECIDED TO RETRIEVE THE IMPLANT ELECTIVELY WHILE STILL IN THE PROCEDURE ROOM. THE LEFT COMMON FEMORAL WAS ACCESSED AND A CROSSOVER SHEATH WAS PLACED FROM LEFT TO RIGHT. THE IMPLANT WAS SNARED AND THE SHEATH, SNARE, AND IMPLANT WERE REMOVED AS ONE UNIT. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS ON THE LEFT COMMON FEMORAL PUNCTURE SITE. THERE WERE NO COMPLICATIONS TO THIS PATIENT AND THE PATIENT WAS DISCHARGED ON TIME THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427281 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD KCLT-6F UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention