BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 9805683 · Received March 9, 2020

    Report

    Report Number
    3009984513-2020-00002
    Event Type
    Injury
    Date Received
    March 9, 2020
    Date of Event
    February 18, 2020
    Report Date
    March 9, 2020
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 NOT POSSIBLE AS LOT NUMBER WAS NO 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.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT A PATIENT RECEIVED A 5F CELT DEVICE IN THE LEFT FEMORAL ARTERY AND 20 MINUTES LATER IT WAS NOTED THAT THE PATIENT HAD LOW BLOOD PRESSURE WHICH LED HIM TO CONCLUDE THAT THE PATIENT WAS HAVING A RETROPERITONEAL BLEED. A CT ANGIOGRAM WAS PERFORMED WHICH SHOWED THE 5F CELT IMPLANT WAS NOT AT THE VESSEL WALL. THE DOCTOR RE-ACCESSED THE LEFT FEMORAL ARTERY VIA A RIGHT FEMORAL ARTERY APPROACH. A 9F SHEATH WAS USED FOR THIS PROCEDURE AND AN 8MM AND A 9MM STENT WERE PLACED IN THE EXTERNAL ILIAC ABOVE THE INGUINAL LIGAMENT TO SEAL THE BLEED. DOCTOR ATTEMPTED TO CLOSE THE RIGHT 9F PUNCTURE WITH A COMPETITOR'S DEVICE. HOWEVER, THIS FAILED AS THE SUTURES PULLED OUT AND IT WAS NECESSARY TO PERFORM A SURGICAL CUT-DOWN AND CLOSE THE 9F HOLE UNDER OPEN VISION. THE PATIENT REMAINED IN HOSPITAL FOR A TOTAL OF 10 DAYS AND DURING THIS PERIOD REQUIRED AN INITIAL 4 UNITS OF BLOOD WHICH WAS FOLLOWED BY A FURTHER 2 UNITS SOME DAYS AFTER THE INITIAL REPAIR PROCEDURE. THE PATIENT WAS DISCHARGED AFTER 10 DAYS WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269429 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-05

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention