FDA Adverse Event
Injury
Summary report: N
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS
MDR report key: 506959
·
Received January 16, 2004
Report
- Report Number
- 2182269-2004-00007
- Event Type
- Injury
- Date Received
- January 16, 2004
- Date of Event
- December 10, 2003
- Report Date
- January 16, 2004
- Manufacturer
- ST. JUDE MEDICAL, DAIG DIVISION, INC.
- Product Code
- MGB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT UNDERWENT SUCCESSFUL ANGIOPLASTY WITH STENT FOLLOWED BY AN ANGIO-SEAL DEPLOYMENT IN THE RIGHT FEMORAL ARTERY IN 2003. THE PT PRESENTED TO THE HOSP EIGHT DAYS LATER, WITH SYMPTOMS OF INFECTION (RED, SORE, TENDER) AT THE PREVIOUS ACCESS SITE. THE PT UNDERWENT SURGERY, WHERE THE ANGI0-SEAL DEVICE WAS REMOVED, THE SITE DEBRIDED, AND THE ARTERY REPAIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS | 6F ANGIO-SEAL STS PLUS | MGB | ST. JUDE MEDICAL, DAIG DIVISION, INC. | NA | 03DJ09 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |