ATHLETIS?
Received Jul 2, 2026 · Event occurred Jun 4, 2026
Report 2124215-2026-35457 · MDR key 25690774
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Boston Scientific CorporationModel number
H74939347070470Catalog number
H74939347070470
Lot number
0036412782
Product problems
- Material Rupture
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7.0MM X 40MM X 75CM ATHLETIS BALLOON CATHETER WAS ADVANCED FOR DILATION. DURING THE SECOND INFLATION AT 10 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT WAS GOOD POST PROCEDURE.
Additional Manufacturer Narrative
A2 - AGE AT TIME OF EVENT: 18 YEARS OR OLDER.