OPTICROSS 18
Report
- Report Number
- 2124215-2025-27617
- Event Type
- Malfunction
- Date Received
- May 14, 2025
- Date of Event
- April 12, 2025
- Report Date
- July 15, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729904366
- PMA / PMN Number
- K160514
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- 003
Narratives
G4 - PREMARKET / 510(K): K160514, K222568.
G4 - PREMARKET / 510(K): K160514, K222568. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED NO ISSUES WERE FOUND, AND THE DEVICE APPEARS TO BE IN GOOD CONDITION. MICROSCOPE INSPECTION REVEALED THE TIP WAS DAMAGED. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.
IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE. UPON CROSSING THE LESION, IT WAS NOTED THAT THE CATHETER TIP BROKE. THE DEVICE WAS REMOVED IN ONCE PIECE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT CATHETER BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. AN OPTICROSS 18 WAS SELECTED FOR USE. UPON CROSSING THE LESION, IT WAS NOTED THAT THE CATHETER TIP BROKE. THE DEVICE WAS REMOVED IN ONCE PIECE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1881845 | OPTICROSS 18 | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H7493932800180 | 0035278928 | 08714729904366 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |