FDA Adverse Event
Injury
Summary report: N
GDC-10 360 COIL
MDR report key: 1033294
·
Received April 22, 2008
Report
- Report Number
- 2939204-2008-00137
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- March 28, 2008
- Report Date
- April 4, 2008
- Manufacturer
- BOSTON SCIENTIFIC IRELAND, CORK, NEUROVASCULAR DIVISION
- Product Code
- HCG
- PMA / PMN Number
- K042539
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
OTHER: FOR NO ALLEGATION OF PRODUCT MALFUNCTION.
Description of Event or Problem · 1
DURING THE EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY ANEURYSM, IT WAS NOTED THAT THE ANEURYSM WAS PERFORATED. IT WAS NOT STATED WHEN THE PERFORATION WAS NOTED OR WHAT ACTION WAS TAKEN TO TREAT THE PERFORATION. PT ASSESSMENT BY MODIFIED RANKING SCALE WAS "3" PRE AND POST PROCEDURE. THE EVENT WAS CONSIDERED RESOLVED WITH NO RESIDUAL EFFECTS BY THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC-10 360 COIL | (HCG) DETACHABLE COIL | HCG | BOSTON SCIENTIFIC IRELAND, CORK, NEUROVASCULAR DIVISION | 346515-SR | 11002084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | TWO BOSTON SCIENTIFIC GDC COILS |