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 2020-03-12 for WEB LOW PROFILE SL-USA W4-6-3FOR US FGA25060-030 manufactured by Sequent Medical, Inc..
[183250072]
A search for non-conformance 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 web was implanted and the delivery system was not returned for evaluation. The root cause cannot be determined. The instructions for use (ifu) identifies hemorrhage and vessel dissection or perforation as potential complications associated with the use of the device.
Patient Sequence No: 1, Text Type: N, H10
[183250073]
It was reported that treatment was performed on an unruptured terminus bifurcation aneurysm in the internal carotid artery. After deployment of the web, an aneurysm rupture and slow bleed was identified. A balloon was inflated and the bleeding stopped. The patient was reported to be "awake and ok" with "no headache" approximately one hour after the procedure. The patient is currently reported to be doing "great. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2020-00061 |
| MDR Report Key | 9827495 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-12 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2018-12-21 |
| Date Added to Maude | 2020-03-12 |
| 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 | WEB LOW PROFILE SL-USA W4-6-3FOR US |
| Generic Name | INTRASACCULAR FLOW DISRUPTION DEVICE |
| Product Code | OPR |
| Date Received | 2020-03-12 |
| Model Number | FGA25060-030 |
| Catalog Number | FGA25060-030 |
| Lot Number | 18122103 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEQUENT MEDICAL, INC. |
| Manufacturer Address | 11 A COLUMBIA ALISO VIEJO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |