MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-02-19 for HEADWAY DUO MICROCATHETER MC162156S manufactured by Microvention, Inc..
[188509462]
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 instructions for use (ifu) identifies vessel dissection as a potential complication associated with use of the device.
Patient Sequence No: 1, Text Type: N, H10
[188509463]
It was reported that during treatment of an aneurysm in a tortuous right posterior inferior cerebellar artery (pica), a possible vessel dissection was identified. There was no reported additional intervention or clinical sequela.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2020-00037 |
| MDR Report Key | 9729982 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-19 |
| Date of Report | 2020-01-20 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-20 |
| Device Manufacturer Date | 2019-06-11 |
| Date Added to Maude | 2020-02-19 |
| 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 | HEADWAY DUO MICROCATHETER |
| Generic Name | DIAGNOSTIC INTRAVASCULAR CATHETER |
| Product Code | DQO |
| Date Received | 2020-02-19 |
| Model Number | MC162156S |
| Catalog Number | MC162156S |
| Lot Number | 19061111Q |
| 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 | 2020-02-19 |