OPTICROSS? 6 HD
Report
- Report Number
- 2124215-2025-23910
- Event Type
- Malfunction
- Date Received
- April 23, 2025
- Date of Event
- April 1, 2025
- Report Date
- June 11, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- UDI-DI
- 08714729960775
- PMA / PMN Number
- K173820
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
G4: PREMARKET / 510(K) # K173820, K213593. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL AND MICROSCOPIC INSPECTIONS REVEALED THAT THE TIP WAS STUCK WITH THE GUIDEWIRE, AND THE GUIDEWIRE EXIT PORT WAS LIFTED AND STUCK. DEVICE ANALYSIS CONFIRMED THE ALLEGATION OF REPORTED EVENT OF CATHETER RESISTANCE/FRICTION. THE RETURNED DEVICE PRESENTED NO DAMAGE WHICH CONFIRM THE REPORTED EVENT OF GUIDEWIRE ENTANGLEMENT.
G4: PREMARKET/510(K) # K173820, K213593.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THET 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE LESION. A PATIENT UNDERGOING TREATMENT FOR CORONARY ARTERY DISEASE (CAD) WAS BEING EVALUATED USING AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER, WHICH WAS PREPARED IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE (DFU) AND ADVANCED INTO THE TARGET VESSEL. DURING THE PROCEDURE, THE CATHETER COULD NOT CROSS AN IMPLANTED UNKNOWN STENT PROXIMAL TO THE LESION DUE TO SIGNIFICANT RESISTANCE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER, THE NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE CAME OUT WITH IT. UPON INSPECTION, THE NON-BSC WIRE WAS FOUND TO BE BONDED TO THE OUTSIDE OF THE CATHETER AND COULD NOT BE SEPARATED. THE CATHETER AND NON-BSC WIRE WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THET 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. AN OPTICROSS 6 HD IMAGING CATHETER WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE LESION. A PATIENT UNDERGOING TREATMENT FOR CORONARY ARTERY DISEASE (CAD) WAS BEING EVALUATED USING AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER, WHICH WAS PREPARED IN ACCORDANCE WITH THE DEVICE INSTRUCTIONS FOR USE (DFU) AND ADVANCED INTO THE TARGET VESSEL. DURING THE PROCEDURE, THE CATHETER COULD NOT CROSS AN IMPLANTED UNKNOWN STENT PROXIMAL TO THE LESION DUE TO SIGNIFICANT RESISTANCE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE CATHETER, THE NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE CAME OUT WITH IT. UPON INSPECTION, THE NON-BSC WIRE WAS FOUND TO BE BONDED TO THE OUTSIDE OF THE CATHETER AND COULD NOT BE SEPARATED. THE CATHETER AND NON-BSC WIRE WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1290865 | OPTICROSS? 6 HD | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H74939354080 | 0035686232 | 08714729960775 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |