BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 19124160 · Received April 17, 2024

    Report

    Report Number
    3009984513-2024-00005
    Event Type
    Malfunction
    Date Received
    April 17, 2024
    Date of Event
    March 19, 2024
    Report Date
    May 2, 2024
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    UDI-DI
    05391530280068
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THERE WAS NO REPORTED PATIENT INJURY OR COMPLICATIONS. A SEARCH OF THE COMPLAINT FILES DID NOT FIND ANY OTHER COMPLAINTS ASSOCIATED TO THE DEVICE LOT NUMBER INVOLVED IN THIS EVENT. THE DEVICE WAS RETURNED FOR EXAMINATION. THE EXAMINATION SHOWED THE 6F DEVICE WAS NOT USED AS PER THE IFU AS IT WAS RETURNED WITH A 7F SHEATH ATTACHED. THE EXAMINATION ALSO IDENTIFIED AN INTERNAL BROKEN PLASTIC COMPONENT. AS THE DEVICE WAS USED OFF-LABEL, THE EXACT CAUSE OF THE BROKEN PART COULD NOT BE CONCLUSIVELY DETERMINED. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM LTD. INVESTIGATION CONCLUSIONS CODE 4247 WAS SELECTED AS THERE'S NO APPROPRIATE CODE FOR "OFF-LABEL USE".

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A SEARCH OF THE COMPLAINT'S FILES DIDN'T FIND ANY OTHER COMPLAINTS ASSOCIATED TO LOT NUMBER INVOLVED ON THIS EVENT. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. THIS REPORT IS THE INITIAL REPORT BEING SUBMITTED BY VASORUM LTD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PHYSICIAN ATTEMPTED TO CLOSE AN ARTERIAL PUNCTURE WITH A CELT ACD VASCULAR CLOSURE DEVICE OF UNKNOWN SIZE. WHEN THE PHYSICIAN ATTEMPTED TO EJECT THE IMPLANT, IT WAS NOTED THAT THE EJECTION FUNCTION DID NOT WORK PROPERLY, AND THE IMPLANT REMAINED CONNECTED TO THE DEVICE (AND THUS STILL IN THE PATIENT). THE PHYSICIAN DECIDED TO PULL THE IMPLANT OUT WHILE STILL CONNECTED TO THE DELIVERY SYSTEM AS ONE UNIT. HE THEN HELD MANUAL COMPRESSION TO ACHIEVE HAEMOSTASIS. THERE WERE NO COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PHYSICIAN ATTEMPTED TO CLOSE AN ARTERIAL PUNCTURE WITH A CELT ACD VASCULAR CLOSURE DEVICE OF UNKNOWN SIZE. WHEN THE PHYSICIAN ATTEMPTED TO EJECT THE IMPLANT, IT WAS NOTED THAT THE EJECTION FUNCTION DID NOT WORK PROPERLY, AND THE IMPLANT REMAINED CONNECTED TO THE DEVICE (AND THUS STILL IN THE PATIENT). THE PHYSICIAN DECIDED TO PULL THE IMPLANT OUT WHILE STILL CONNECTED TO THE DELIVERY SYSTEM AS ONE UNIT. HE THEN HELD MANUAL COMPRESSION TO ACHIEVE HAEMOSTASIS. THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232500 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-06 942883 05391530280068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention