MalfunctionMOU

B-RAIL

Received Feb 2, 2015 · Event occurred Jan 29, 2015

Report 4507759 · MDR key 4507759

Device

Generic name

Intravascular Radiation Delivery System

Manufacturer

Best Vascular, Inc.

Model number

Catalog number

Lot number

BW0138

Product problems

Failure to Deliver

Patient

55 YR

No Information

Narrative

Description of Event or Problem

NOVOSTE B-RAIL INSERTED BY THE INTERVENTIONAL CARDIOLOGIST INTO CIRCUMFLEX ARTERY FOR INTRA-CORONARY RADIATION THERAPY TREATMENT. RADIATION SEEDS WOULD NOT DELIVER THROUGH CATHETER, CATHETER WAS REMOVED AND A SECOND DEVICE USED WITHOUT ISSUE.