ATHLETIS?
Received Jul 6, 2026 · Event occurred Jun 11, 2026
Report 2124215-2026-36115 · MDR key 25728052
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Boston Scientific CorporationModel number
H74939347060450Catalog number
H74939347060450
Lot number
0033997247
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 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT FOREARM SHUNT VEIN SIDE. A 6.0MM X 40MM X 50CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE PROCEDURE, THE BALLOON RUPTURED UPON FIRST INFLATION AT 15 ATMOSPHERES FOR 10 SECONDS. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.