inforMED
OtherMOU

NOVOSTE 30MM BETA-CATH SYSTEM

Received Oct 26, 2001 · Event occurred Sep 26, 2001

Report 1062385-2001-00016 · MDR key 359128

Device

Generic name

Transfer Device/catheter

Model number

A1732/510609-030

Catalog number

WLC-0001-032/BCK-0130

Lot number

NA/UNK

Product problems

  • Application Program Problem: Dose Calculation Error
  • Misapplication
  • Inaccurate Delivery

Patient

*

  • Therapy/non-surgical treatment, unncessary

Narrative

Description of Event or Problem

NRC EVENT REPORT INDICATES THAT A PT UNDERGOING TREATMENT FOR RESTENOSIS OF A CARDIAC VESSEL REC'D A 23 GRAY DOSE USING A SV-90 SOURCE VIA INTRAVASCULAR BRACHYTHERAPY. THE ERROR OCCURRED DUE TO DIFFICULTY IN RESOLVING THE CORRECT VESSEL SEGMENT LOCATION USING FLUOROSCOPY IMAGING. THE ATTENDING RADIOLOGIST AND CARDIOLOGIST REVIEWED FILM CONCLUDING THAT THE WRONG SEGMENT HAD BEEN TREATED. THE PRESCRIBED DOSE WAS THEN DELIVERED TO THE CORRECT SITE. THE PT HAS NOT BEEN INFORMED AND THERE ARE NO ADVERSE EFFECTS ANTICIPATED. THE LICENSEE WILL MEET WITH THE VENDOR TO DISCUSS APPROPRIATE CORRECTIVE ACTIONS IN USE OF THE EQUIPMENT.