CELT ACD PLUS VASCULAR CLOSURE DEVICE
Report
- Report Number
- 3009984513-2025-00006
- Event Type
- Injury
- Date Received
- May 22, 2025
- Date of Event
- April 25, 2025
- Report Date
- June 12, 2025
- Manufacturer
- VASORUM LTD.
- Product Code
- MGB
- UDI-DI
- 05391530280679
- PMA / PMN Number
- P150006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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 FILES DID NOT FIND ANY OTHER REPORT WITH THE LOT NUMBER (943286). THE DEVICE WAS NOT 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. NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS THE INTIAL REPORT BEING SUBMITTED BY VASORUM LTD.
DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A SEARCH OF THE COMPLAINT FILES DID NOT FIND ANY OTHER REPORT WITH THE LOT NUMBER (943286). THE DEVICE WAS NOT 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. 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 PHYSICIAN USED A 7F CELT ACD PLUS DEVICE TO CLOSE AN 8F ARTERIOTOMY AFTER A 4-HOUR CORONARY CTO PROCEDURE. THE DEVICE WAS RETRACTED TO WHAT WAS THOUGHT TO BE THE ARTERIOTOMY AFTER THE DISTAL WING WAS DEPLOYED. UPON RAISING TO 90 DEGREES THE BLOOD SIGNAL DID NOT COMPLETELY STOP SO PHYSICIAN MADE MULTIPLE ATTEMPTS TO RETRACT FURTHER AND ELEVATE AGAIN. THE BLOOD SIGNAL APPEARED TO STOP. UPON DEPLOYMENT OF THE PROXIMAL WING THE DEVICE APPEARED TO JUMP UPWARD SLIGHTLY. IMPLANT WAS EJECTED, BLEEDING WAS NOTED AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS FOR APPROXIMATELY 1 HOUR. THE PHYSICIAN ELECTED TO GIVE A BLOOD TRANSFUSION SINCE THE PATIENT WAS BECOMING HYPOTENSIVE, AND THE PATIENT WAS THEN REASSESSED AND AN ATTEMPT TO ACHIEVE HAEMOSTATIC CONTROL WITH AN ANGIOPLASTY BALLOON WAS NOT SUCCESSFUL. PATIENT WAS THEN BROUGHT TO SURGERY TO REPAIR THE ARTERIOTOMY. PATIENT WAS REPORTED TO BE OK AND SURGERY SUCCESSFUL.
IT WAS REPORTED THAT PHYSICIAN USED A 7F CELT ACD PLUS DEVICE TO CLOSE AN 8F ARTERIOTOMY AFTER A 4-HOUR CORONARY CTO PROCEDURE. THE DEVICE WAS RETRACTED TO WHAT WAS THOUGHT TO BE THE ARTERIOTOMY AFTER THE DISTAL WING WAS DEPLOYED. UPON RAISING TO 90 DEGREES THE BLOOD SIGNAL DID NOT COMPLETELY STOP SO PHYSICIAN MADE MULTIPLE ATTEMPTS TO RETRACT FURTHER AND ELEVATE AGAIN. THE BLOOD SIGNAL APPEARED TO STOP. UPON DEPLOYMENT OF THE PROXIMAL WING THE DEVICE APPEARED TO JUMP UPWARD SLIGHTLY. IMPLANT WAS EJECTED, BLEEDING WAS NOTED AND MANUAL COMPRESSION WAS USED TO ACHIEVE HEMOSTASIS FOR APPROXIMATELY 1 HOUR. THE PHYSICIAN ELECTED TO GIVE A BLOOD TRANSFUSION SINCE THE PATIENT WAS BECOMING HYPOTENSIVE, AND THE PATIENT WAS THEN REASSESSED AND AN ATTEMPT TO ACHIEVE HAEMOSTATIC CONTROL WITH AN ANGIOPLASTY BALLOON WAS NOT SUCCESSFUL. PATIENT WAS THEN BROUGHT TO SURGERY TO REPAIR THE ARTERIOTOMY. PATIENT WAS REPORTED TO BE OK AND SURGERY SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1220527 | CELT ACD PLUS VASCULAR CLOSURE DEVICE | VASCULAR CLOSURE DEVICE | MGB | VASORUM LTD. | KCLT-07 | 943286 | 05391530280679 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention| H |