OPTICROSS 18
Report
- Report Number
- 2124215-2025-54055
- Event Type
- Malfunction
- Date Received
- August 6, 2025
- Date of Event
- July 14, 2025
- Report Date
- September 23, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- PMA / PMN Number
- K160514
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION SHOWS THE SHEATH AND IMAGING WINDOW WERE KINKED. MICROSCOPIC INSPECTION REVEALED THE GUIDEWIRE EXIT PORT WAS LIFTED, BUT THE DISTAL SECTION OF THE TIP WAS IN GOOD CONDITION. A TEST GUIDEWIRE WAS INSERTED, AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. G4: PREMARKET / 510(K) #: K160514, K222568.
G4: PREMARKET / 510(K) #: K160514, K222568. G1 MFR CONTACT FIRST NAME, MFR CONTACT LAST NAME: CORRECTION.
G4: PREMARKET / 510(K) #: K160514, K222568.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED PERIPHERAL ARTERY. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR USE IN THE ULTRASOUND EXAMINATION. DURING THE PROCEDURE, THE CATHETER BECAME KINKED MID SHAFT AND WRAPPED AROUND THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE CATHETER WAS EXCHANGED, AND THE SAME THING HAPPENED WITH A NEW OPTICROSS 18 IMAGING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED PERIPHERAL ARTERY. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR USE IN THE ULTRASOUND EXAMINATION. DURING THE PROCEDURE, THE CATHETER BECAME KINKED MID SHAFT AND WRAPPED AROUND THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE CATHETER WAS EXCHANGED, AND THE SAME THING HAPPENED WITH A NEW OPTICROSS 18 IMAGING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.
IT WAS REPORTED THAT A CATHETER ISSUE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED PERIPHERAL ARTERY. AN OPTICROSS 18 IMAGING CATHETER WAS SELECTED FOR USE IN THE ULTRASOUND EXAMINATION. DURING THE PROCEDURE, THE CATHETER BECAME KINKED MID SHAFT AND WRAPPED AROUND THE NON-BOSTON SCIENTIFIC GUIDEWIRE. THE CATHETER WAS EXCHANGED, AND THE SAME THING HAPPENED WITH A NEW OPTICROSS 18 IMAGING CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1765753 | OPTICROSS 18 | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H7493932800180 | 0036162469 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | ABBOTT SPARTACORE GUIDEWIRE| ABBOTT SPARTACORE GUIDEWIRE| ABBOTT SPARTACORE GUIDEWIRE |