DeathHBZ

OCCLUSION BALLOON CATHETER

Received May 22, 1996 · Event occurred May 20, 1996

Report 33531 · MDR key 33531

Device

Generic name

Occlusion Balloon Catheter

Manufacturer

Interventinal Therapeutics Corp.

Catalog number

NDSR 1505/3000Z

Lot number

9598

Product problems

Reaction

Patient

62 YR

Death
Rupture
Respiratory Failure

Narrative

Description of Event or Problem

DURING THE COURSE OF A CEREBRAL ANGIOGRAM AND BALLOON OCCLUSION OF THE BASILAR ARTERY, THE PT'S ANEURYSM RUPTURED AND THE PT UNDERWENT A RESPIRATORY ARREST.