FDA Adverse Event
Malfunction
Summary report: N
OPTICROSS? 6 HD
MDR report key: 23427277
·
Received October 30, 2025
Report
- Report Number
- 2124215-2025-78173
- Event Type
- Malfunction
- Date Received
- October 30, 2025
- Date of Event
- October 13, 2025
- Report Date
- October 30, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729960775
- PMA / PMN Number
- K173820
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
G4 PREMARKET / 510(K): K173820, K213593.
Description of Event or Problem · 0
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN A SMALL, CALCIFIED, AND TORTUOUS DIAGONAL BRANCH. THE OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. DURING THE PROCEDURE, THE DEVICE WAS DIFFICULT TO ADVANCE. WHEN THE CATHETER WAS REMOVED, THE GUIDEWIRE WAS ALSO REMOVED BECAUSE THE CATHETER WAS WRAPPED AROUND THE GUIDEWIRE. A NEW GUIDEWIRE WAS USED TO COMPLETE THE INTERVENTION WITH NO FURTHER ISSUES. THERE WERE NO PATIENT COMPLICATIONS. THE CATHETER WAS NOTED TO BE KINKED IN THE MONORAIL PORTION, AND THE TIP WAS DAMAGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2251050 | OPTICROSS? 6 HD | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H74939354080 | 08714729960775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |