OPTICROSS? HD
Report
- Report Number
- 2124215-2025-32450
- Event Type
- Malfunction
- Date Received
- May 20, 2025
- Date of Event
- April 27, 2025
- Report Date
- August 7, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729960737
- PMA / PMN Number
- K173284
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
G4 PREMARKET / 510(K) #: K213593.
G4 PREMARKET / 510(K) #: K213593 DEVICE EVALUATED BY MANUFACTURER: THE RETURNED DEVICE PRESENTED NO DAMAGE, AND THE DEVICE APPEARS TO BE IN GOOD CONDITION. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE REPORTED COMPLAINT IS NOT CONFIRMED.
IT WAS REPORTED THAT SHEATH DETACHMENT OCCURRED. DURING A POST-PCI IVUS RUN, IT WAS DETERMINED THAT THE OPTICROSS HD HAD SEPARATED INTERNALLY, THE OUTER SLEEVE REMAINED IN THE VESSEL WHILE THE INNER SLEEVE WAS NEAR THE CATHETER-SLED CONNECTION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH NO REPORTED ADVERSE OUTCOME.
IT WAS REPORTED THAT SHEATH DETACHMENT OCCURRED. DURING A POST-PCI IVUS RUN, IT WAS DETERMINED THAT THE OPTICROSS HD HAD SEPARATED INTERNALLY, THE OUTER SLEEVE REMAINED IN THE VESSEL WHILE THE INNER SLEEVE WAS NEAR THE CATHETER-SLED CONNECTION. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE WITH NO REPORTED ADVERSE OUTCOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71835 | OPTICROSS? HD | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H74939352040 | 0035738629 | 08714729960737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |