STERLING
Received Jul 8, 2026 · Event occurred Jun 12, 2026
Report 2124215-2026-36533 · MDR key 25745554
Device
Generic name
Catheter, Percutaneous
Manufacturer
Boston Scientific CorporationModel number
24700Catalog number
24700
Lot number
0038404532
Product problems
- Material Rupture
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 4.0MMX40MMX40CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. THE BALLOON WAS INFLATED FOUR TIMES AT 10 ATMOSPHERES FOR 30 SECONDS EACH. DURING THE FOURTH INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.