BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 9574020 · Received January 10, 2020

    Report

    Report Number
    3009984513-2019-00022
    Event Type
    Injury
    Date Received
    January 10, 2020
    Date of Event
    December 11, 2019
    Report Date
    January 10, 2020
    Manufacturer
    VASORUM LTD
    Product Code
    MGB
    UDI-DI
    05391530280228
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A REVIEW OF THE LOT RECORD WAS CONDUCTED WITH NO RELEVANT FINDINGS. 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.

    Description of Event or Problem · 1

    PATIENT HAD UNDERGONE A SUCCESSFUL DEPLOYMENT OF A 6F CELT ON (B)(6) 2019. IT WAS NOTED AT THE TIME A HEMATOMA WHICH WAS RESOLVED UNEVENTFULLY. ON (B)(6) 2019 PATIENT PRESENTED TO THE HOSPITAL FOR A FURTHER PROCEDURE (AIF). ON THIS OCCASION THE DOCTOR USED A 6F ACCESS SHEATH THROUGH THE RIGHT COMMON FEMORAL ARTERY AND USING A CROSSOVER TECHNIQUE USED A 014 GUIDEWIRE FROM THE RIGHT GROIN AND DOWN THE COMMON FEMORAL ARTERY PAST THE CELT WHICH WAS PRESENT AT THE BIFURCATION OF THE SUPERFICIAL AND PROFUNDA FEMORUS ON THE LEFT SIDE. DESPITE MULTIPLY ATTEMPTS USING VARIOUS 5F SHEATHS, LASER CATHETERS AND ANGIOPLASTY BALLOONS, IT WAS NOT POSSIBLE FOR THE PHYSICIAN TO PASS THE STENOSIS AT THE SITE OF THE IMPLANTED CELT. ON THE X-RAY PROVIDED, FURTHER STENOSIS IS EVIDENT ALONG THE LENGTH OF THE PROFUNDA FEMORIS ARTERY. DURING THE PROCEDURE THE PATIENT APPARENTLY THROMBOSED THE RIGHT ILIAC ARTERY AND AN INFUSION CATHETER WAS INSERTED IN ORDER TO COMMENCE A THROMBOLYTIC DRIP (TPA). DUE TO THE SEVERITY OF THE STENOSIS, THE PATIENT WAS REFERRED FOR SURGICAL REPAIR OF THE SITE OF THE STENOSIS WHICH APPEARS TO EXTEND FOR ABOUT 2CM BEYOND THE SITE OF THE IMPLANTED CELT. ON (B)(6) 2020 IT WAS REPORTED THAT PATIENT'S STENOSIS WAS FIXED BY VASCULAR SURGERY, PATIENT RECOVERED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38402 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD KCLT-06 814023 05391530280228

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention