FDA Adverse Event
Malfunction
Summary report: N
HYPERGLIDE OCCLUSION BALLOON SYSTEM
MDR report key: 3232712
·
Received July 18, 2013
Report
- Report Number
- 2029214-2013-00626
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 21, 2013
- Report Date
- June 26, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MJN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).
Description of Event or Problem · 1
TREATMENT OF AN IC-PC (INTERNAL CAROTID-POSTERIOR CAROTID) ANEURYSM. DURING THE PREPARATION, IT WAS REPORTED THAT THE HYPERGLIDE BALLOON RUPTURED DURING TEST INFLATION. THE DEVICE WAS NOT USED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335736 | HYPERGLIDE OCCLUSION BALLOON SYSTEM | OCCLUSION BALLOON SYSTEM | MJN | EV3 NEUROVASCULAR | 104-4113 | NOT REPORTED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |