CELT ACD PLUS VASCULAR CLOSURE DEVICE
Report
- Report Number
- 3009984513-2025-00008
- Event Type
- Injury
- Date Received
- September 19, 2025
- Report Date
- September 19, 2025
- Manufacturer
- VASORUM LTD.
- Product Code
- MGB
- PMA / PMN Number
- P150006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A SEARCH OF THE COMPLAINT FILESWAS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. THE DEVICE WAS NOT RETURNED TO VASORUM LTD. FOR EXAMINATION. IT IS PRESUMED THAT THE IMPLANT IS STILL IN THE PATIENT AS NO DESCRIPTION OF HAVING IT REMOVED WAS PROVIDED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN THE CUSTOMER COMPLAINT FILES OF VASORUM LTD FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS THE FINAL REPORT BEING SUBMITTED BY VASORUM LTD.
IT WAS REPORTED THAT AFTER DEPLOYMENT, THE 6F CELT ACD PLUS GOT CAUGHT ON PLAQUE AND DISSECTED THE INTIMA OF THE BLOOD VESSEL. THE OPERATOR REPORTED THAT OPENING THE PROXIMAL WING DID NOT SEAL THE ARTERIOTOMY AND MANUAL PRESSURE WAS APPLIED AT THE ACCESS SITE. HEMOSTASIS WAS ACHIEVED WITH MANUAL PRESSURE. ACCESS WAS GAINED FROM THE OTHER LEG AND A STENT WAS DEPLOYED AT THE AFFECTED DISSECTED AREA. IT IS PRESUMED THAT THE IMPLANT IS STILL IN THE PATIENT AS NO DESCRIPTION OF HAVING IT REMOVED WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1766917 | CELT ACD PLUS VASCULAR CLOSURE DEVICE | VASCULAR CLOSURE DEVICE | MGB | VASORUM LTD. | CLT-06 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |