MalfunctionLIT
STERLING?
Received Jul 6, 2026 · Event occurred Jun 9, 2026
Report 2124215-2026-36146 · MDR key 25728084
Device
Generic name
Catheter, Percutaneous
Manufacturer
Boston Scientific CorporationModel number
H74939032202210Catalog number
H74939032202210
Lot number
0038951837
Product problems
- Material Rupture
Patient
78 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 40% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL BELOW THE KNEE. A 4.0MMX40MMX80CM (4F) STERLING BALLOON WAS ADVANCED FOR DILATION. HOWEVER, DURING THE SECOND INFLATION AT THE NOMINAL PRESSURE FOR ABOUT 30 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ANY PROBLEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.