FDA Adverse Event
Malfunction
Summary report: N
GDC 10-ULTRASOFT STRETCH RESISTANT COIL SYNERG DETECTION CIR
MDR report key: 560272
·
Received December 16, 2004
Report
- Report Number
- 6000078-2004-00227
- Event Type
- Malfunction
- Date Received
- December 16, 2004
- Date of Event
- October 8, 2004
- Report Date
- December 15, 2004
- Manufacturer
- BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
BOSTON SCIENTIFIC WAS NOTIFIED THAT DURING AN EVENT THE GDC 10-ULTRASOFT STRETCH RESISTANT COIL SYNERG DETECTION CIRCUIT DETACHED INSIDE THE TRANSIT MICROCATHETER. NO COMPLICATIONS WITH THE PT WERE REPORTED DURING THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GDC 10-ULTRASOFT STRETCH RESISTANT COIL SYNERG DETECTION CIR | DETACHABLE COIL | HCG | BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION | * | 5497636 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | TRANSIT MICROCATHETER |