FDA Adverse Event
Injury
Summary report: N
8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS
MDR report key: 515607
·
Received March 12, 2004
Report
- Report Number
- 2182269-2004-00042
- Event Type
- Injury
- Date Received
- March 12, 2004
- Report Date
- March 12, 2004
- Manufacturer
- ST. JUDE MEDICAL, DAIG DIVISION, INC.
- Product Code
- MGB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED AN ANGIO-SEAL DEVICE WAS DEPLOYED TO SEAL THE ARTERIOTOMY SITE IN 2004. THE PT PRESENTED TO THE HOSP WITH SIGNS OF INFECTION AT THE GROIN SITE (DATE UNKNOWN). ONE WEEK LATER, THE PT UNDERWENT SURGERY; THE ANGIO-SEAL DEVICE WAS REMOVED. THE PT WAS REPORTED TO BE RECOVERING AND DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS | 8F ANGIO-SEAL STS | MGB | ST. JUDE MEDICAL, DAIG DIVISION, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |