FDA Adverse Event
Injury
Summary report: N
GDC DETACHABLE COIL
MDR report key: 1522750
·
Received November 3, 2009
Report
- Report Number
- 2939204-2009-00824
- Event Type
- Injury
- Date Received
- November 3, 2009
- Date of Event
- October 16, 2009
- Report Date
- October 23, 2009
- Manufacturer
- NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP.
- Product Code
- HCG
- PMA / PMN Number
- K031049
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADD'L PMA?510(K): K042539. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION OR NONCONFORMANCE RELATED TO THE USE OF THESE DEVICES IN THE INDEX PROCEDURE.
Description of Event or Problem · 1
DURING A ROUTINE TWELVE MONTH F/U VISIT ANGIOGRAPHY REVEALED A WORSENING OF THE ANEURYSM OCCLUSION, RAYMOND SCALE OF 2. A SECOND PROCEDURE WAS THEN PERFORMED TO REOCCLUDE THE ANEURYSM. THERE WAS NO REPORTED CLINICAL CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC DETACHABLE COIL | HCG | NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | BOSTON SCIENTIFIC| BOSTON SCIENTIFIC| GDC-10 360 SR COIL, MODEL# M003346715SR0| GDC-10 360 SR COIL, MODEL# M003346920SR0| GDC-10 ULTRASOFT COIL, MODEL# M033432020| BOSTON SCIENTIFIC| BOSTON SCIENTIFIC| ELEVEN GDC COILS (BOSTON SCIENTIFIC)| TWO GDC-10 ULTRASOFT COIL, MODEL# M0033432040| THREE GDC-10 360 SOFT SR COIL, MODEL#M003447306SR0| BOSTON SCIENTIFIC| GDC-10 360 SR COIL, MODEL# M00333461030SR0| THREE GDC-10 360 SR COILS, MODEL# M003346820SR0| BOSTON SCIENTIFIC| BOSTON SCIENTIFIC |