CELT ACD PLUS VASCULAR CLOSURE DEVICE
Report
- Report Number
- 3009984513-2025-00011
- Event Type
- Injury
- Date Received
- December 16, 2025
- Date of Event
- December 4, 2025
- Report Date
- May 19, 2026
- Manufacturer
- VASORUM LTD.
- Product Code
- MGB
- UDI-DI
- 05391530280648
- PMA / PMN Number
- P150006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
DURING PROCESSING OF THIS COMPLAINT AN ATTEMPT WAS MADE TO OBTAIN COMPLETE EVENT INFORMATION. A SEARCH OF THE COMPLAINT FILES WAS COMPLETED, AND NO OTHER COMPLAINTS WERE IDENTIFIED WITH THE SAME LOT NUMBER. A REVIEW OF THE LOT RECORDS DID NOT IDENTIFY ANY NON-CONFORMANCES OR ISSUES DURING THE PRODUCTION OF THIS PARTICULAR LOT. THE DEVICE IS BEING RETURNED TO VASORUM LTD. VASORUM LTD HAVE NOT YET RECEIVED THE DEVICE FOR EXAMINATION. THE IMPLANT WAS NOT IMPLANTED, AND THE PATIENT WAS REPORTED AS STABLE POST PROCEDURE. 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.
IT WAS REPORTED THAT A PHYSICIAN DEPLOYED STEP ONE AND TWO, ATTEMPTED TO EJECT THE IMPLANT AND THE CLIP WOULDN'T DETACH AFTER THE LEVER WAS PUSHED. THE DELIVERY SYSTEM AND THE IMPLANT WAS PULLED OUT AND MANUAL PRESSURE APPLIED, FOLLOWED BY FEMSTOP APPLICATION. HEMOSTASIS WAS ACHIEVED. THE DEVICE IS BEING RETURNED TO VASORUM LTD FOR INSPECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2393 | CELT ACD PLUS VASCULAR CLOSURE DEVICE | VASCULAR CLOSURE DEVICE | MGB | VASORUM LTD. | CLT-06 | 943528 | 05391530280648 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Other |