BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELT ACD VASCULAR CLOSURE DEVICE

    MDR report key: 19547314 · Received June 17, 2024

    Report

    Report Number
    3009984513-2024-00008
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    May 30, 2024
    Report Date
    July 8, 2024
    Manufacturer
    VASORUM LTD.
    Product Code
    MGB
    PMA / PMN Number
    P150006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. A SEARCH OF THE COMPLAINT'S FILES DIDN'T FIND ANY OTHER REPORT WITH THE POSSIBLE LOT NUMBERS (943037, 943043, 943017). THE DEVICE WAS RETURNED TO VASORUM LTD. FOR EXAMINATION. 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. HEALTH EFFECT - CLINICAL CODE 4581 WAS USED AS NO OTHER FEASIBLE CODE WAS FOUND FOR THE PREFERRED TERM "NO OBSERVABLE CLINICAL SYMPTOMS BUT CLINICAL DECISION TAKEN TO REMOVE THE IMPLANT ON THE BASIS THAT FUTURE SYMPTOMS MIGHT DEVELOP". INVESTIGATION FINDINGS CODE 4247 WAS USED AS NO OTHER FEASIBLE CODE WAS FOUND FOR THE PREFERRED TERM "DAMAGE CAUSED BY ABNORMAL 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 REPORT WITH THE POSSIBLE LOT NUMBERS (943037, 943043, 943017). THE DEVICE IS BEING RETURNED TO VASORUM LTD. FOR EXAMINATION. 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 THE PHYSICIAN ATTEMPTED TO USE A 6F CELT ACD TO CLOSE A 6F ARTERIAL PUNCTURE. PHYSICIAN BELIEVED THE DEVICE WAS DEPLOYED PROPERLY. UPON EJECTION IT WAS REPORTED THE DEVICE DID NOT WORK AND THAT THE DISTAL TIP WAS BROKEN. FLUOROSCOPY SHOWED THE IMPLANT EMBOLIZED INTO THE TP TRUNK. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT WAS SUBSEQUENTLY SENT TO THE HOSPITAL TO HAVE THE IMPLANT RETRIEVED VIA SURGICAL REMOVAL. IT IS UNKNOWN WHETHER OR NOT THE PATIENT HAD SYMPTOMS OF THE EMBOLIZATION OR IF THE PHYSICIAN SIMPLY DECIDED TO HAVE THE IMPLANT SURGICALLY REMOVED AS A PRECAUTION. THE DELIVERY SYSTEM HAS BEEN RETURNED TO VASORUM LTD FOR EXAMINATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE A 6F CELT ACD TO CLOSE A 6F ARTERIAL PUNCTURE. PHYSICIAN BELIEVED THE DEVICE WAS DEPLOYED PROPERLY. UPON EJECTION IT WAS REPORTED THE DEVICE DID NOT WORK AND THAT THE DISTAL TIP WAS BROKEN. FLUOROSCOPY SHOWED THE IMPLANT EMBOLIZED INTO THE TP TRUNK. MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS. THE PATIENT WAS SUBSEQUENTLY SENT TO THE HOSPITAL TO HAVE THE IMPLANT RETRIEVED VIA SURGICAL REMOVAL. IT IS UNKNOWN WHETHER OR NOT THE PATIENT HAD SYMPTOMS OF THE EMBOLIZATION OR IF THE PHYSICIAN SIMPLY DECIDED TO HAVE THE IMPLANT SURGICALLY REMOVED AS A PRECAUTION. THE DELIVERY SYSTEM IS BEING RETURNED TO VASORUM LTD FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331860 CELT ACD VASCULAR CLOSURE DEVICE VASCULAR CLOSURE DEVICE MGB VASORUM LTD. KCLT-06 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention