OPTICROSS 6 HD
Report
- Report Number
- 2124215-2024-73521
- Event Type
- Malfunction
- Date Received
- November 25, 2024
- Date of Event
- September 1, 2024
- Report Date
- December 9, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729960775
- PMA / PMN Number
- K173820
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
G4 PREMARKET / 510(K) # - K173820, K213593
B3 DATE OF EVENT WAS ESTIMATED BASED ON THE AWARE DATE AS THE EVENT DATE WAS NOT REPORTED. G4 PREMARKET / 510(K) # - K173820, K213593. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTION REVEALED THE IMAGING WINDOW WAS TWISTED. VISUAL INSPECTION SHOWED NO DAMAGES OR FAILURES WITH THE CATHETER CODE PCBA BOARD ASSEMBLY. MICROSCOPIC INSPECTION SHOWED THE GUIDEWIRE EXIT PORT AND THE DISTAL SECTION OF THE TIP WERE IN GOOD CONDITION. IMPEDANCE TESTING SHOWED AN ELECTRICAL OPEN AT THE PROXIMAL END OF THE CATHETER BETWEEN 100-110 CM FROM THE DISTAL HOUSING.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. GOOD IMAGING WAS NOT ABLE TO BE OBTAINED, AND THE MATERIAL BECAME TWISTED OUTSIDE THE PATIENT.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE OPTICROSS 6 HD WAS ADVANCED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. GOOD IMAGING WAS NOT ABLE TO BE OBTAINED, AND THE MATERIAL BECAME TWISTED OUTSIDE THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2235681 | OPTICROSS 6 HD | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H74939354080 | 0034373690 | 08714729960775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |