OPTICROSS? 6 HD
Report
- Report Number
- 2124215-2025-28663
- Event Type
- Malfunction
- Date Received
- May 7, 2025
- Date of Event
- April 10, 2025
- Report Date
- July 3, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729960775
- PMA / PMN Number
- K173820
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
G4 - PREMARKET / 510(K) #: K213593.
G4 - PREMARKET / 510(K) #: K213593.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD WAS ADVANCED FOR AN ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER GOT STUCK ON NON-BOSTON SCIENTIFIC WIRE AFTER STARTING AUTO-PULLBACK. THE CATHETER AND WIRE WERE PULLED OUT TO REMOVE THEM FROM THE BODY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THE PATIENT IS STABLE AND THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. AN OPTICROSS 6 HD WAS ADVANCED FOR AN ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE CATHETER GOT STUCK ON NON-BOSTON SCIENTIFIC WIRE AFTER STARTING AUTO-PULLBACK. THE CATHETER AND WIRE WERE PULLED OUT TO REMOVE THEM FROM THE BODY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THE PATIENT IS STABLE AND THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1820555 | OPTICROSS? 6 HD | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H74939354080 | 0034945951 | 08714729960775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |