CELT ACD VASCULAR CLOSURE DEVICE
Report
- Report Number
- 3009984513-2018-00002
- Event Type
- Injury
- Date Received
- October 25, 2018
- Date of Event
- September 21, 2018
- Report Date
- April 4, 2019
- Manufacturer
- VASORUM LTD
- Product Code
- MGB
- UDI-DI
- 05391530280082
- PMA / PMN Number
- P150006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- 003
Narratives
DURING THE PROCESS OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. VASORUM LTD IS SUBMITTING THIS REPORT ON THE BEHALF OF (B)(4), IN ACCORDANCE WITH THE CONDITIONS OUTLINED WITH THE MDR EXEMPTION E2017048. VASORUM LTD, TRINITAS HOUSE, 2012 ORCHARD AVENUE, CITYWEST BUSINESS PARK, D24 WPW6, DUBLIN - IRELAND. (B)(4).
DEVICE WAS DEPLOYED ACCORDING TO THE PROPER STEPS, BUT WASN'T PULLED ALL THE WAY TO THE ARTERIOTOMY BEFORE TURNING STEP 2. IT WAS THEN RELEASED IN THE VESSEL. DOCTOR RE-ACCESSED IN THE SAME LOCATION AND PLACED A 6 X/ 40MM ZILVER STENT TO CAPTURE THE DEVICE AGAINST THE WALL OF THE SFA.
DURING THE PROCESS OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.
DEVICE WAS DEPLOYED ACCORDING TO THE PROPER STEPS, BUT WASN'T PULLED ALL THE WAY TO THE ARTERIOTOMY BEFORE TURNING STEP 2. IT WAS THEN RELEASED IN THE VESSEL. DOCTOR RE-ACCESSED IN THE SAME LOCATION AND PLACED A 6 X/ 40MM ZILVER STENT TO CAPTURE THE DEVICE AGAINST THE WALL OF THE SFA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 848005 | CELT ACD VASCULAR CLOSURE DEVICE | VASCULAR CLOSURE DEVICE | MGB | VASORUM LTD | KCLT-6F | 654934 | 05391530280082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |