FDA Adverse Event
Other
Summary report: N
MICROVENTION HEADWAY DUO STRONG
MDR report key: 23019080
·
Received September 10, 2025
Report
- Report Number
- MW5175890
- Event Type
- Other
- Date Received
- September 10, 2025
- Manufacturer
- MICROVENTION, INC.
- Product Code
- DQO
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT UNDERWENT LEFT MIDDLE MENINGEAL ARTERY EMBOLIZATION FOR TREATMENT OF CHRONIC LEFT SUBDURAL HEMATOMA. DURING THE EMBOLIZATION PROCEDURE THE CATHETER TIP BECAME STUCK IN THE N-BCA EMBOLIZATION AGENT. THE TIP OF THE MICROCATHETER TIP WAS RETAINED WITHIN THE DISTAL PARIETAL BRANCH OF LEFT MIDDLE MENINGEAL ARTERY. THE PHYSICIAN HAS COMPLETED THIS PROCEDURE WITH THIS EMBOLIC AGENT AND MICROCATHETER WITH NO PROBLEMS PREVIOUSLY. NO DIFFERENCES IN TECHNIQUE OCCURRED PER THE PROVIDER. CATHETER: MICROVENTION HEADWAY DUO STRONG; 156 CM REF# (B)(4) LOT: 0001149785 EMBOLIC AGENT/GLUE: CERENOVUS TRUFILL N-BCA REF#: (B)(4), LOT: M9571J.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2706856 | MICROVENTION HEADWAY DUO STRONG | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | MICROVENTION, INC. | MC162156S | 0001149785 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | CERENOVUS TRUFILL N-BCA REF#: (B)(4), LOT: M9571J. THERAPY START AND END DATE. |