STERLING?
Report
- Report Number
- 2124215-2025-63217
- Event Type
- Malfunction
- Date Received
- September 9, 2025
- Date of Event
- August 13, 2025
- Report Date
- December 4, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LIT
- UDI-DI
- 08714729859611
- PMA / PMN Number
- K141150
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4 - PREMARKET / 510(K) #: K141150, K162350.
UPDATED E1: INITIAL REPORTER FIRST NAME. UPDATED E1: INITIAL REPORTER EMAIL. G4 - PREMARKET / 510(K) #: K141150, K162350.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX150MMX150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER FIRST INFLATION AT 10 ATMOSPHERES. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 6.0MMX150MMX150CM STERLING BALLOON CATHETER WAS ADVANCED FOR DILATATION. DURING THE PROCEDURE, THE BALLOON RUPTURED AFTER FIRST INFLATION AT 10 ATMOSPHERES. THE DEVICE WAS REMOVED USING NORMAL METHOD WITHOUT ISSUE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2406858 | STERLING? | CATHETER, PERCUTANEOUS | LIT | BOSTON SCIENTIFIC CORPORATION | H74939031601610 | 0030024882 | 08714729859611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |