STERLING SL
Received Jul 7, 2026 · Event occurred Jun 8, 2026
Report 2124215-2026-36153 · MDR key 25738396
Device
Generic name
Catheter, Angioplasty, Peripheral, Transluminal
Manufacturer
Boston Scientific CorporationModel number
H74939148308010Catalog number
H74939148308010
Lot number
0038734954
Product problems
- Material Rupture
Patient
Not reported
- Foreign Body In Patient
- Vascular Dissection
Narrative
Additional Manufacturer Narrative
E1 (INITIAL PHONE NUMBER): (B)(6).
Description of Event or Problem
IT WAS REPORTED THAT BALLOON BURST OCCURRED. A 3.0MM X 80MM X 150CM STERLING WAS SELECTED FOR USE IN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE. DURING THE PROCEDURE, THE BALLOON BURST AND MATERIAL FROM THE BALLOON AND BALLOON MARKER REMAINED IN THE PATIENT. THE BALLOON MATERIAL WAS SECURED IN THE DISSECTION MEMBRANE AND FIXED WITH A STENT. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON AND A STENT WAS PLACED.