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 2019-04-23 for VIA 21 MICROCATHETER FGA21154-01 manufactured by Sequent Medical, Inc.
[142869542]
The lot number was provided. A review of the approved device history records indicated the lot met all release criteria. A lot history trending review was performed and there were no similar complaints for this lot number. The device was not returned to the manufacturer for evaluation; therefore, a product analysis could not be performed. The root cause is unknown.
Patient Sequence No: 1, Text Type: N, H10
[142869543]
It was reported that during treatment for a basilar artery apex aneurysm, a 6f neuromax guiding sheath and a sofia catheter were used together with the via 21 microcatheter. After initial placement of the catheters, there was a pause in fluoroscopy and upon resuming fluoro, digital road mapping images demonstrated movement of the via catheter. Subsequent angiography demonstrated contrast extravasation from the dome of the aneurysm with resulting subarachnoid hemorrhage. Heparin was reversed and the via 21 was removed and replaced with an sl-10 microcatheter, and an occlusion balloon was positioned in the basilar artery to prevent blood flow to the aneurysm. Embolization coils were then deployed in the aneurysm and subsequent angiography confirmed that bleeding had stopped. An external ventricular drain (evd) was inserted to relieve/monitor intracranial pressures. It was reported that patient had no stroke, but had significant edema in the brain. The patient was taken to the icu and has been kept heavily sedated since the procedure to prevent patient movement and brain swelling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2019-00102 |
| MDR Report Key | 8542393 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-23 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-03-25 |
| Device Manufacturer Date | 2019-02-11 |
| Date Added to Maude | 2019-04-23 |
| 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. DEBBY CALLAHAN |
| 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 | VIA 21 MICROCATHETER |
| Generic Name | MICROCATHETER |
| Product Code | OPR |
| Date Received | 2019-04-23 |
| Model Number | FGA21154-01 |
| Catalog Number | FGA21154-01 |
| Lot Number | 19021106 |
| 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. Other; 2. Required No Informationntervention | 2019-04-23 |