FDA Adverse Event
Malfunction
Summary report: N
HYDROCOIL 14-SYSTEM COIL (HES)
MDR report key: 1060981
·
Received June 12, 2008
Report
- Report Number
- 2032493-2008-00012
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- April 19, 2008
- Report Date
- May 16, 2008
- Manufacturer
- MICROVENTION, INC.
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SAMPLE ANALYSIS: SAMPLE WAS NOT RETURNED FOR EVAL. ROOT CAUSE ANALYSIS; THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEPLOYMENT OF THE EMBOLIZATION COIL, THE COIL PREMATURELY DETACHED PARTIALLY IN THE ARTERY. THERE WAS NO CLINICAL SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDROCOIL 14-SYSTEM COIL (HES) | EMBOLIZATION COIL | HCG | MICROVENTION, INC. | 140720HES | P0709125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |