FDA Adverse Event
Death
Summary report: N
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE STS
MDR report key: 516621
·
Received March 18, 2004
Report
- Report Number
- 2182269-2004-00049
- Event Type
- Death
- Date Received
- March 18, 2004
- Report Date
- March 18, 2004
- Manufacturer
- ST. JUDE MEDICAL, DAIG DIVISION, INC.
- Product Code
- MGB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED FOLLOWING A STENT PLACEMENT AND PRE-DEPLOYMENT FEMORAL ANGIOGRAM, AN ANGIO-SEAL DEVICE WAS USED TO SEAL THE ARTERIOTOMY SITE. THE PT RECEIVED HEPARIN AT THE END OF THE PROCEDURE PER HOSPITAL PROTOCOL. THE PT AMBULATED APPROXIMATELY THREE HOURS LATER. THREE HOURS FOLLOWING INITIAL AMBULATION, THE PT COMPLAINED OF NOT FEELING WELL AND REPORTEDLY HEARD A "POP" AT THE GROIN SITE. PT THEN COMPLAINED OF CHEST PAIN AND BLEEDING WAS NOTED FROM THE GROIN SITE. MANUAL PRESSURE AND A FEMOSTOP WERE APPLIED; HEMOSTASIS WAS NOT ACHIEVED. THE PT BECAME HYPOTENSIVE, SUFFERED A MYOCARDIAL INFARCTION, AND WENT INTO COMPLETE HEART BLOCK. ATTEMPTS AT TEMPORARY PACING WERE UNSUCCESSFUL AND THE PT EXPIRED.
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, DAIG DIVISION, INC. | NA | 1046933 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Death | 1. HEPARIN,| 2. REOPRO (DOSE UNKNOWN) 2004. |