FDA Adverse Event
Malfunction
Summary report: N
GDC 10-SOFT SYNERG DETECTION CIRCUIT
MDR report key: 493707
·
Received October 30, 2003
Report
- Report Number
- 6000078-2003-00176
- Event Type
- Malfunction
- Date Received
- October 30, 2003
- Date of Event
- October 2, 2003
- Manufacturer
- BOSTON SCIENTIFIC CORP. NEUROVASCULAR DIV.
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
BOSTON SCIENTIFIC WAS NOTIFIED THAT DURING THE PROCEDURE THE GDC 10-SOFT SYNERG DETECTION CIRCUIT BROKE WHILE IN THE EXCELSIOR SL-10 MICROCATHETER. NO COMPLICATIONS WERE REPORTED WITH THE PT AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC 10-SOFT SYNERG DETECTION CIRCUIT | DETACHABLE COIL | HCG | BOSTON SCIENTIFIC CORP. NEUROVASCULAR DIV. | * | 5767520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | BRAND NAME: EXCELSIOR SL-10 MICROCATHETER,| CATALOG #: 168189, LOT #: 5809202, EXPIRATION| DATE: 08/31/2005. |