FDA Adverse Event
Malfunction
Summary report: N
MICROPLEX 10-SYSTEM COIL (MCS)
MDR report key: 1060983
·
Received June 12, 2008
Report
- Report Number
- 2032493-2008-00011
- Event Type
- Malfunction
- Date Received
- June 12, 2008
- Date of Event
- April 5, 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: A PORTION OF THE DELIVERY PUSHER WAS RETURNED FOR ANALYSIS. THE MOST DISTAL AND PROXIMAL ENDS OF THE PUSHER ARE REMOVED FROM DEVICE, AND NOT AVAILABLE FOR ANALYSIS. A TORQUE DEVICE IS LOCATED ON PROXIMAL END OF PUSHER, HUB HAS BEEN REMOVED FROM DEVICE. THE DISTAL END OF THE ASSEMBLY IS STRETCHED AND CRUSHED. THE IMPLANT IS NOT INCLUDED FOR ANALYSIS. ROOT CAUSE ANALYSIS: THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PHYSICIAN COULD NOT DETACH AN EMBOLIZATION COIL. UPON ATTEMPTED WITHDRAW, THE COIL STRETCHED AND BROKE. NO CLINICAL SEQUELAE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MICROPLEX 10-SYSTEM COIL (MCS) | EMBOLIZATION COIL | HCG | MICROVENTION, INC. | 100930HC-R | P0709045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |