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 HEADWAY DUO MICROCATHETER UNKNOWN manufactured by Microvention, Inc.
[186753291]
The lot number was not provided. A search for non-conformances associated with this part/lot number combination could not be conducted. The device was not returned to the manufacturer for evaluation. The root cause cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
[186753292]
It was reported that stent-assisted coiling was performed on an a-com aneurysm. The lvis jr. Stent was placed across the neck of the aneurysm, jailing the duo microcatheter. Four (4) coils were subsequently implanted in the aneurysm without issue. During placement of the fifth coil, the microcatheter "kicked" out of the aneurysm. A slight perforation of the parent vessel wall opposite the aneurysm was identified. Heparin was reversed and a pipeline flow diverter was implanted within the lvis jr. Stent. The patient woke up "fine" and without any problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2032493-2020-00078 |
| MDR Report Key | 9891784 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| 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 | HEADWAY DUO MICROCATHETER |
| Generic Name | DIAGNOSTIC INTRAVASCULAR CATHETER |
| Product Code | DQO |
| Date Received | 2020-03-27 |
| Model Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROVENTION, INC |
| Manufacturer Address | 35 ENTERPRISE DRIVE ALISO VIEJO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |