MalfunctionLOX
NC Emerge
Received Jul 29, 2026 · Event occurred Jul 9, 2026
Report 2124215-2026-40525 · MDR key 50065314
Device
Generic name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Manufacturer
Boston Scientific CorporationModel number
7311Catalog number
7311
Lot number
0039108231
Product problems
- Material Rupture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
It was reported that balloon rupture occurred. A 4.50mm x 8mm NC Emerge balloon catheter was advanced for dilatation. However, during the second inflation at 18 atmospheres for 10, the balloon ruptured. The device was removed, and the procedure was completed with another of the same device. There were no patient complications reported and the patient was in good condition.