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 2020-02-03 for WEB LOW PROFILE SL-USA W4-4-3FOR US FGA25040-030 manufactured by Sequent Medical, Inc.
[177590508]
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 device was implanted in the patient. The root cause of the complaint cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[177590509]
It was reported that treatment was performed for a ruptured anterior communicating artery (pericallosal) aneurysm. The patient had not been given anticoagulant medication before the procedure. A post-deployment angiogram demonstrated normal flow in the a-com artery; however, a clot was identified at the neck of the aneurysm and on the web device. A bolus of integrilin was administered and full flow was restored. There was no reported clinical sequela.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2020-00020 |
| MDR Report Key | 9662629 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-04 |
| Date of Event | 2020-01-04 |
| Date Mfgr Received | 2020-01-04 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-02-03 |
| 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 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WEB LOW PROFILE SL-USA W4-4-3FOR US |
| Generic Name | WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM |
| Product Code | OPR |
| Date Received | 2020-02-03 |
| Model Number | FGA25040-030 |
| Catalog Number | FGA25040-030 |
| Lot Number | 19081929 |
| 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 92656 US 92656 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-03 |