BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 8128570 · Received December 4, 2018

    Report

    Report Number
    3009984513-2018-00003
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    November 5, 2018
    Report Date
    April 4, 2019
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    UDI-DI
    05391530280068
    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 OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. VASORUM LTD IS SUBMITTING THIS REPORT ON THE BEHALF OF DJ MEDICAL CONSULTING & DISTRIBUTION LLC, IN ACCORDANCE WITH THE CONDITIONS OUTLINED WITH THE MDR EXEMPTION E2017048. VASORUM LTD. (B)(4). DJ MEDICAL CONSULTING AND DISTRIBUTION LLC. (B)(4).

    Description of Event or Problem · 0

    DEVICE WAS DEPLOYED ON (B)(6) 2018. PATIENT HAD NO KNOWN SYMPTOMS POST DISCHARGE. ON (B)(6) 2018, THE PATIENT WAS BROUGHT IN FOR AN ANGIOGRAM AND THE IMPLANT WAS DISCOVERED IN THE RIGHT SFA. THE DOCTOR ATTEMPTED TO SNARE THE DEVICE VIA ANTEGRADE ACCESS. DURING THIS PROCESS THE DEVICE WAS LOST IN THE ORIGIN OF THE PROFUNDA ON THE CONTRALATERAL LEG. THE DOCTOR THEN PERFORMED CONTRALATERAL ACCESS ON THE RIGHT LEG, SNARED THE DEVICE AND DROPPED IT INTENTIONALLY IN A BRANCH OF THE INTERNAL ILIAC BECAUSE THIS IS A LOCATION WHERE BLOOD CAN EASILY PERFUSE AROUND THE IMPLANT AND CAUSE NO CLINICAL SEQUELLAE.

    Additional Manufacturer Narrative · 1

    DURING THE PROCESSING OF THIS COMPLAINT ALL ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Description of Event or Problem · 1

    DEVICE WAS DEPLOYED ON (B)(6) 2018. PATIENT HAD NO KNOWN SYMPTOMS POST DISCHARGE.ON (B)(6) 2018 THE PATIENT WAS BROUGHT IN FOR AN ANGIOGRAM AND THE IMPLANT WAS DISCOVERED IN THE RIGHT SFA. THE DOCTOR ATTEMPTED TO SNARE THE DEVICE VIA ANTEGRADE ACCESS. DURING THIS PROCESS THE DEVICE WAS LOST IN THE ORIGIN OF THE PROFUNDA ON THE CONTRALATERAL LEG. THE DOCTOR THEN PERFORMED CONTRALATERAL ACCESS ON THE RIGHT LEG, SNARED THE DEVICE AND DROPPED IT INTENTIONALLY IN A BRANCH OF THE INTERNAL ILIAC BECAUSE THIS IS A LOCATION WHERE BLOOD CAN EASILY PERFUSE AROUND THE IMPLANT AND CAUSE NO CLINICAL SEQUELLAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968660 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-6F 632628 05391530280068

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention