FDA Adverse Event
Injury
Summary report: N
MATRIX2 STANDARD 2D SR COIL
MDR report key: 1071401
·
Received July 7, 2008
Report
- Report Number
- 2939204-2008-00252
- Event Type
- Injury
- Date Received
- July 7, 2008
- Date of Event
- April 4, 2008
- Report Date
- June 9, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV.
- Product Code
- HCG
- PMA / PMN Number
- K050700
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FOR NO ALLEGED MALFUNCTION OR NONCONFORMANCE OF THE DEVICE.
Description of Event or Problem · 1
THE PT UNDERWENT SUCCESSFUL BALLOON ASSISTED EMBOLIZATION OF A RIGHT POSTERIOR COMMUNICATING ARTERY ANEURYSM. POST PROCEDURE THE PT SUFFERED A STROKE WITH SIGNS OF POSTERIOR CEREBRAL ARTERY ISCHEMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MATRIX2 STANDARD 2D SR COIL | (HCG) DETACHABLE COIL | HCG | BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIV. | 471620-SR | 7874427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| O | TWO BOSTON SCIENTIFIC MATRIX2 COILS| A GDC COIL| A BALLOON CATHETER| MAKE AND MODEL UNK |