inforMED

3.5F BETA-RAIL DELIVERY CATHETER

Received Mar 11, 2003

Report 1062385-2003-00003 · MDR key 448110

Device

Generic name

Catheter

Manufacturer

Novoste Corp.

Model number

P00563

Catalog number

ABR-0340

Lot number

UNK

Product problems

  • Unknown (for use when the device problem is not known)

Patient

*

  • Intimal Dissection
  • Hospitalization required

Narrative

Description of Event or Problem

THE COMPLAINANT REPORTED THAT THE PT WAS TREATED WITH BALLOON ANGIOPLASTY THEN WITH BRACHYTHERAPY. FOLLOWING THE BRACHYTHERAPY PROCEDURE, THE CARDIOLOGIST NOTED A DISSECTION FROM THE PROXIMAL PORTION OF THE ARTERY TO THE DISTAL AND REFERRED THE PT TO BYPASS SURGERY. THE PT STATUS IS STABLE.