FDA Adverse Event
Injury
Summary report: N
HYPERFORM OCCLUSION BALLOON SYSTEM
MDR report key: 3033740
·
Received April 3, 2013
Report
- Report Number
- 2029214-2013-00309
- Event Type
- Injury
- Date Received
- April 3, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 6, 2013
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MJN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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
BALLOON ASSISTED COILING OF AN MCA (MIDDLE CEREBRAL ARTERY) ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PARENT VESSEL RUPTURED POSSIBLY DUE TO THE REPEATED INFLATION OF THE BALLOON. THE PHYSICIAN ATTEMPTED TO OCCLUDE THE ICA (INTERNAL CAROTID ARTERY) BY OVER-INFLATING THE BALLOON AND INADVERTENTLY RUPTURING THE BALLOON IN THE PROCESS. IT WAS REPORTED THAT THE PATIENT HAD A SUBARACHNOID HEMORRHAGE AND WAS INTUBATED IN THE ITU (INTENSIVE THERAPY UNIT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136411 | HYPERFORM OCCLUSION BALLOON SYSTEM | OCCLUSION BALLOON SYSTEM | MJN | EV3 NEUROVASCULAR | 104-4370 | 9630868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Disability |