FDA Adverse Event
Injury
Summary report: N
HYDROCOIL 14-SYSTEM DETACHABLE COIL (HES)
MDR report key: 2103680
·
Received May 23, 2011
Report
- Report Number
- 2032493-2011-00012
- Event Type
- Injury
- Date Received
- May 23, 2011
- Date of Event
- April 25, 2011
- Report Date
- April 25, 2011
- Manufacturer
- MICROVENTION, INC.
- Product Code
- HCG
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SAMPLE ANALYSIS: THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. THE ROOT CAUSE OF THIS COMPLAINT CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE DEPLOYMENT OF AN EMBOLIZATION COIL RESISTANCE WAS ENCOUNTERED, UPON REMOVAL, THE COIL PREMATURELY DETACHED IN THE VESSEL. AN INTRAVASCULAR SNARE WAS USED TO RETRIEVE THE COIL SUCCESSFULLY. NO HARM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDROCOIL 14-SYSTEM DETACHABLE COIL (HES) | EMBOLIZATION COIL | HCG | MICROVENTION, INC. | 140620HES-V | P101025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |