FDA Adverse Event
Death
Summary report: N
HYPERGLIDE OCCLUSION BALLOON SYSTEM
MDR report key: 1013165
·
Received March 13, 2008
Report
- Report Number
- 2029214-2008-00042
- Event Type
- Death
- Date Received
- March 13, 2008
- Date of Event
- January 28, 2008
- Report Date
- February 14, 2008
- Manufacturer
- EV3 NEUROVASCULAR
- Product Code
- MJN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE BALLOON CATHETER HAS BEEN EVALUATED AND CONFIRMED THE CATHETER LEAKED AT APPROXIMATELY 2.5MM FROM THE DISTAL TIP OF THE CATHETER. BALLOON LEAKED.
Description of Event or Problem · 1
COILING TREATMENT OF AN INTERNAL CAROTID ARTERY ANEURYSM. IT WAS REPORTED DURING THE PROCEDURE, THE BALLOON COULD NOT BE INFLATED AND LEAKAGE WAS DETECTED AT THE TIP. THE BALLOON CATHETER WAS THEN WITHDRAWN FROM THE PT. ANOTHER BALLOON CATHETER WAS THEN USED. DURING THE COILING PROCEDURE, THE ANEURYSM RUPTURED CAUSING SUBARACHNOID HEMORRHAGE AND CAROTID-CAVERNOUS FISTULA. BOTH COMPLICATIONS WERE TREATED; HOWEVER, THE PT WAS REPORTED TO HAVE EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HYPERGLIDE OCCLUSION BALLOON SYSTEM | OCCLUSION BALLOON CATHETER | MJN | EV3 NEUROVASCULAR | 104-4112 | 4000952 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death |