BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 14206505 · Received April 26, 2022

    Report

    Report Number
    3009984513-2022-00003
    Event Type
    Injury
    Date Received
    April 26, 2022
    Report Date
    April 26, 2022
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS ASSOCIATE TO LITERATURE: MALDEPLOYMENT OF CELT ACD VASCULAR CLOSURE DEVICE. A SEARCH OF THE LOT RECORD WAS NOT POSSIBLE AS LOT NUMBER WAS NOT PROVIDED. THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM UNLESS OTHERWISE REQUESTED BY THE FDA. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 0

    A (B)(6) MAN HAD UNDERGONE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) ATHERECTOMY VIA RETROGRADE RIGHT FEMORAL ARTERY ACCESS USING A 6F, 45-CM LONG PINNACLE SHEATH AT AN OFFICE-BASED LABORATORY. CLOSURE OF THE RIGHT FEMORAL ARTERY AT THE PUNCTURE SITE WAS PERFORMED USING A CELT CLOSURE DEVICE. THE PATIENT DEVELOPED A RIGHT FEMORAL PSEUDOANEURYSM AND HAD RECEIVED A SUCCESSFUL THROMBIN INJECTION THE DAY AFTER THE PROCEDURE. THE PATIENT HAD SUBSEQUENTLY DEVELOPED SYMPTOMS OF INTERMITTENT CLAUDICATION OF THE RIGHT LOWER EXTREMITY WHEN WALKING 100 YARDS WITH AN EASILY PALPABLE RIGHT FEMORAL PULSE BUT ABSENT POPLITEAL POSTERIOR TIBIAL AND DORSALIS PEDIS PULSES AND AN ANKLE BRACHIAL INDEX OF 0.6 ON THE RIGHT. AN ARTERIOGRAM OF THE RIGHT LOWER EXTREMITY VIA A LEFT FEMORAL APPROACH SHOWED THE CELT DEVICE IN THE RIGHT DISTAL SFA WITH NEAR OCCLUSION OF THE ARTERY. FIVE DAYS AFTER THE PATIENT'S INITIAL PROCEDURE, THE PATIENT UNDERWENT REMOVAL OF THE CELT DEVICE VIA A LONGITUDINAL INCISION IN THE LOWER THIGH. AT THE SAME PROCEDURE, A RIGHT SFA ENDARTERECTOMY WAS PERFORMED BECAUSE THE CLOSURE DEVICE WAS INTIMATELY ADHERENT TO THE ARTERIAL WALL. A BOVINE PERICARDIAL PATCH REPAIR WAS PERFORMED, WITH RESTORATION OF THE DISTAL PULSES IN THE RIGHT LOWER EXTREMITY AND AN ANKLE BRACHIAL INDEX OF 1.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206567 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention