MICROPLEX COMPLEX COIL 18-SYSTEM (MCS) Adverse Event — Malfunction (MDR 2032493-2008-00003)
MICROPLEX COMPLEX COIL 18-SYSTEM (MCS) Adverse Event — Malfunction (MDR 2032493-2008-00003) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MICROPLEX COMPLEX COIL 18-SYSTEM (MCS); Generic name: EMBOLIZATION COIL; Manufacturer: MICROVENTION, INC..
| Device | MICROPLEX COMPLEX COIL 18-SYSTEM (MCS) |
|---|---|
| Generic name | EMBOLIZATION COIL |
| Manufacturer | MICROVENTION, INC. |
| Report number | 2032493-2008-00003 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-12 |
| Report source | Health Professional, Company representation |
| Narrative | IT IS UNCLEAR TO THE MANUFACTURER AS TO WHAT ACTUALLY OCCURRED DURING THIS INCIDENT. HOWEVER, THE FOLLOWING INFORMATION HAS BEEN RECEIVED; THE PHYSICIAN ATTEMPTED TO DEPLOY THE THIRD COIL IN A 2 CM CAROTID ANEURYSM. A WIRE DETACHED FROM THE PUSHER MANDREL. AS THE COIL COULD NOT BE REMOVED FROM THE PATIENT, THE PHYSICIAN LEFT IT PARTIALLY BROKEN IN THE DESCENDING AORTA. THE ANEURYSM EMBOLIZATION WA |
| Source | openFDA MAUDE (device adverse events) |
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