FDA Adverse Event
Malfunction
Summary report: N
NANO COILS TARGET
MDR report key: 6760466
·
Received July 31, 2017
Report
- Report Number
- MW5071338
- Event Type
- Malfunction
- Date Received
- July 31, 2017
- Date of Event
- January 23, 2017
- Report Date
- July 31, 2017
- Manufacturer
- STRYKER
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
CEREBRAL ANEURYSM COILING FOR SAH; COIL WOULD NOT DEPLOY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535548 | NANO COILS TARGET | DEVICE, NEUROVASCULAR EMBOLIZATION | HCG | STRYKER | 544204 | 19329086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Other |