FDA Adverse Event
Death
Summary report: N
STARCLOSE VASCULAR CLOSURE SYSTEM
MDR report key: 851375
·
Received May 7, 2007
Report
- Report Number
- 2953144-2007-00599
- Event Type
- Death
- Date Received
- May 7, 2007
- Date of Event
- April 5, 2007
- Report Date
- April 10, 2007
- Manufacturer
- ABBOTT VASCULAR INC.
- Product Code
- MGB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED AND THERE WAS NO LOT INFORMATION. WE WERE NOT ABLE TO PERFORM DEVICE INSPECTION OR DEVICE HISTORY RECORD REVIEW IN THIS CASE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE, SUCCESSFULLY COMPLETED AN ARTERIOTOMY CLOSURE AFTER A CORONARY INTERVENTIONAL PROCEDURE. NINETY MINUTES AFTER THE PROCEDURE, THE PATIENT COMPLAINED OF ABDOMINAL PAIN. THE PATIENT CODED AND THEN PASSED AWAY. THE POST MORTEM CONCLUDED A RETROPERITONEAL BLEED WAS THE CAUSE OF DEATH DUE TO A "DOUBLE WALL STICK." NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STARCLOSE VASCULAR CLOSURE SYSTEM | VASCULAR CLOSURE SYSTEM | MGB | ABBOTT VASCULAR INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Death | INTEGRILIN |