OPTICROSS? HD
Report
- Report Number
- 2124215-2025-87245
- Event Type
- Malfunction
- Date Received
- December 11, 2025
- Date of Event
- November 1, 2025
- Report Date
- December 16, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729960737
- PMA / PMN Number
- K173284
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
B3 DATE OF EVENT WAS ESTIMATED BASED ON THE AWARE DATE AS THE EVENT DATE WAS UNKNOWN. G4: PREMARKET / 510(K) # K173284, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION REVEALED THE SHEATH ASSEMBLY WAS KINKED. 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 DISTAL END OF THE CATHETER; 0-10 CM FROM THE DISTAL HOUSING.
B3 DATE OF EVENT WAS ESTIMATED BASED ON THE AWARE DATE AS THE EVENT DATE WAS UNKNOWN. G4: PREMARKET / 510(K) # K173284, K213593. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION FOR THE TARGET LESION. DURING THE PROCEDURE, IMAGING STARTED AND STOPPED ON ITS OWN. UPON REMOVAL, THE CATHETER TIP WAS FOUND BROKEN. THE DEVICE WAS REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION FOR THE TARGET LESION. DURING THE PROCEDURE, IMAGING STARTED AND STOPPED ON ITS OWN. UPON REMOVAL, THE CATHETER TIP WAS FOUND BROKEN. THE DEVICE WAS REMOVED IN ONE PIECE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2772542 | OPTICROSS? HD | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H74939352040 | 0036793247 | 08714729960737 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |