FDA Adverse Event
Injury
Summary report: N
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS
MDR report key: 694569
·
Received March 31, 2006
Report
- Report Number
- 2182269-2006-00072
- Event Type
- Injury
- Date Received
- March 31, 2006
- Date of Event
- March 1, 2006
- Report Date
- March 31, 2006
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- MGB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A 6F ANGIO-SEAL STS VASCULAR CLOSURE DEVICE WAS USED TO SEAL THE ARTERIOTOMY SITE POST DIAGNOSITC CARDIAC ANGIOGRAPHY PROCEDURE. A PRE-PLACEMENT ANGIOGRAM WAS OBTAINED, THE ANGIO-SEAL WAS DEPLOYED, AND HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS DISCHARGED. THE PATIENT COMPLAINED OF SYMPTOMS OF CLAUDICATION IN THE RIGHT LEG. A DOPPLER ULTRASOUND REVEALED STENOSIS IN THE RIGHT COMMON FEMORAL ARTERY AT THE LEVEL OF THE PUNCTURE SITE. THE INCIDENT DATE IS MONTH SPECIFIC. THE PATIENT'S CASE WAS BEING REVIEWED BY VASCULAR SURGEONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS | 6F ANGIO-SEAL STS | MGB | ST. JUDE MEDICAL | NA | 1188768 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Other |