FDA Adverse Event
Injury
Summary report: N
MIRAGE .008 HYDROPHILIC GUIDEWIRE
MDR report key: 1032527
·
Received April 22, 2008
Report
- Report Number
- 2029214-2008-00074
- Event Type
- Injury
- Date Received
- April 22, 2008
- Date of Event
- February 25, 2008
- Report Date
- March 25, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- DQX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED FOR EVALUATION.
Description of Event or Problem · 1
WHILE PERFORMING AN EMBOLIZATION PROCEDURE WITH A MICROCATHETER AND MIRAGE GUIDEWIRE, IT WAS REPORTED THAT THE GUIDEWIRE DID NOT RESPOND IN THE SUPRACLINOID REGION OF ICA. WHEN THE GUIDEWIRE WAS REMOVED, THE DISTAL SEGMENT OF THE GUIDEWIRE WAS LEFT IN THE ICA. THE PHYSICIAN WAS UNABLE TO REMOVE IT WITH AN ENDOVASCULAR LOOP [SNARE] AND USED AN INTRACRANIAL STENT TO AVOID MIGRATION OF THE SEGMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MIRAGE .008 HYDROPHILIC GUIDEWIRE | GUIDEWIRE | DQX | EV3 NEUROVASCULAR | 103-0608 | 4920954 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Disability |