FDA Adverse Event
Malfunction
Summary report: N
HYDROCOIL 14-SYSTEM (HES)
MDR report key: 1003759
·
Received February 22, 2008
Report
- Report Number
- 2032493-2008-00004
- Event Type
- Malfunction
- Date Received
- February 22, 2008
- Date of Event
- January 24, 2008
- Report Date
- January 25, 2008
- Manufacturer
- MICROVENTION, INC.
- Product Code
- HCG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE HES 14-SYSTEM COIL HAS NOT BEEN RETURNED FOR EVALUATION.
Description of Event or Problem · 1
THE PHYSICIAN SUCCESSFULLY DEPLOYED SEVERAL COILS INTO ANEURYSM. HALF WAY THROUGH THE PROCEDURE, ONE COIL DETACHED PREMATURELY IN THE ANEURYSM DURING REPOSITIONING. THE MOST DISTAL 10CM OF THE COIL WERE INSERTED INTO ANEURYSM FOR APPROX 1 MINUTE. THE MICROCATHETER WAS CLOSE TO THE ANEURYSM NECK. HALF OF THE COIL WAS WITHIN THE ANEURYSM AND HALF IN THE MICROCATHETER. THE COIL WAS REMOVED USING A LASSO. THERE WAS NO RESISTANCE FROM THE PART OF THE COIL WITHIN THE ANEURYSM. THERE WAS NO HARM TO THE PT REPORTED. THERE WAS NO ADVERSE EVENT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYDROCOIL 14-SYSTEM (HES) | EMBOLIZATION COIL | HCG | MICROVENTION, INC. | 140820HES-V | P0710173 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |