MalfunctionLLZ
System, image processing, radiological
Received Jul 5, 2026 · Event occurred Jun 12, 2026
Report 2124215-2026-35904 · MDR key 25712935
Device
Generic name
System, Image Processing, Radiological
Manufacturer
Boston Scientific CorporationProduct problems
- Material Rupture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. AN UNKNOWN BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE SECOND, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT REMAINED STABLE.