FDA Adverse Event
Death
Summary report: N
GDC 18-STANDARD SYNERG DETECTION CIRCUIT
MDR report key: 833405
·
Received March 30, 2007
Report
- Report Number
- 6000078-2007-00095
- Event Type
- Death
- Date Received
- March 30, 2007
- Date of Event
- January 16, 2007
- Report Date
- March 5, 2007
- Manufacturer
- BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
- Product Code
- HCG
- PMA / PMN Number
- k991134
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXPLANTED DATE: THIS FIELD DOES NOT APPLICABLE AS THE DEVICE REMAINS IMPLANTED. ADD'L 510(K)# K001083.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT WITH A 16MM ANEURYSM BETWEEN THE LEFT INTERNAL CAROTID ARTERY (LICA) AND THE OPHTHALMIC ARTERY (OPHA) WAS TREATED 2007. THE PROCEDURE WAS REPORTEDLY COMPLETED WITHOUT INCIDENT. PATIENT CAME OUT OF ANESTHESIA FINE. HOWEVER, NINE HOURS LATER, THE PATIENT EXPIRED. COMPUTED AXIAL TOMOGRAPHY (CT) IMAGES SHOWED A HEMORRHAGE WITHIN THE CRANIUM. THE PHYSICIAN IS UNSURE WHAT CAUSED THE PATIENT'S DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC 18-STANDARD SYNERG DETECTION CIRCUIT | (84 HCG) DETACHABLE COIL | HCG | BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION | 3481030 | 7520443 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Death | 5 MICROPLEX COIL| EXCELSIOR 1018 MICROCATHETER| TRANSEDED SOFT TIP GUIDE WIRE| 4 GDC-18 360 COIL |