MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for HYDROSOFT 3D ADVANCED 7110-0308-3D-A2 7110-0308 manufactured by Microvention, Inc..
[186751990]
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device. The device was not returned to the manufacturer for evaluation. The root cause cannot be determined. The coil detachment occurred after the aneurysm perforation; therefore, the device malfunction did not cause or contribute to the adverse event. Additionally, it is unknown if the coil or the microcatheter (not a microvention device) perforated the aneurysm.
Patient Sequence No: 1, Text Type: N, H10
[186751991]
It was reported that treatment was performed for a choroidal aneurysm. During placement of the embolization coil, the aneurysm was perforated. During the attempt to retract the coil, the coil stretched and then detached. Another coil was placed in the aneurysm, which was successful in stopping the extravasation. The detached coil segment was then removed from the patient with a stent retriever. The patient woke up from anesthesia. The patient was reported to have had a stroke, but was slowly improving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2020-00075 |
| MDR Report Key | 9892316 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-11-19 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. EVA MANUS |
| Manufacturer Street | 35 ENTERPRISE DRIVE |
| Manufacturer City | ALISO VIEJO, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYDROSOFT 3D ADVANCED |
| Generic Name | VASCULAR EMBOLIZATION DEVICE |
| Product Code | HCG |
| Date Received | 2020-03-27 |
| Model Number | 7110-0308-3D-A2 |
| Catalog Number | 7110-0308 |
| Lot Number | 1811195W6 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROVENTION, INC. |
| Manufacturer Address | 35 ENTERPRISE ALISO VIEJO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-03-27 |