FDA Adverse Event
Malfunction
Summary report: N
HYPERFORM OCCLUSION BALLOON SYSTEM
MDR report key: 2460580
·
Received February 17, 2012
Report
- Report Number
- 2029214-2012-00066
- Event Type
- Malfunction
- Date Received
- February 17, 2012
- Date of Event
- January 20, 2012
- Report Date
- January 20, 2012
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- NUF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EVALUATED. THE BALLOON CATHETER WAS FOUND LEAKED AT 1.5MM FROM THE DISTAL TIP AND NOT RUPTURED. (B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BALLOON WAS USED TO ASSIST IN AN ANEURYSM COILING PROCEDURE. AFTER DEPLOYED TWO COILS, THE BALLOON COULD NOT MAINTAINED INFLATE AND WAS FOUND RUPTURED. NO PATIENT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYPERFORM OCCLUSION BALLOON SYSTEM | OCCLUSION BALLOON CATHETER | NUF | EV3 NEUROVASCULAR | 104-4771 | 8133066 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |