FDA Adverse Event
Malfunction
Summary report: N
OPTICROSS¿ HD
MDR report key: 23887839
·
Received December 24, 2025
Report
- Report Number
- 23887839
- Event Type
- Malfunction
- Date Received
- December 24, 2025
- Date of Event
- November 11, 2025
- Report Date
- December 8, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- ITX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DURING PREP THE HUB DISCONNECTED FROM THE CATHETER. THE CATHETER WAS REMOVED AND REPLACED. MANUFACTURER RESPONSE FOR CORONARY IMAGING CATHETER, 5FR OPTICROSS 60 MHZ HD CORONARY IMAGING CATHETER BAGLESS (PER SITE REPORTER).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2381096 | OPTICROSS¿ HD | TRANSDUCER, ULTRASONIC, DIAGNOSTIC | ITX | BOSTON SCIENTIFIC CORPORATION | H74939352050 | 37326346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |