OPTICROSS 18
Report
- Report Number
- 2124215-2024-70727
- Event Type
- Malfunction
- Date Received
- November 19, 2024
- Date of Event
- October 1, 2024
- Report Date
- December 18, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OBJ
- PMA / PMN Number
- K160514
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
B3: DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 10/01/2024 AS THE EXACT EVENT DATE WAS NOT REPORTED. G4: ADDITIONAL PREMARKET/510(K): K222568. THE DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, AN ANALYSIS WAS CONCLUDED BASED ON THE RECEIVED PHOTO OF THE COMPLAINT DEVICE. THE MEDIA SHOWS THE IMAGING WINDOW TWISTED AND KINKED, AND THE IMAGING CORE WAS OBSERVED TWISTED.
B3 - DATE OF EVENT: DATE OF EVENT WAS APPROXIMATED TO 10/01/2024 AS THE EXACT EVENT DATE WAS NOT REPORTED. G4 - ADDITIONAL PRE-MARKET / 510(K): K222568.
IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER GETS ALL TWIRLED UP AND CANNOT BE USED AGAIN. KINK WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
IT WAS REPORTED THAT CATHETER ISSUE OCCURRED. AN OPTICROSS 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER GETS ALL TWIRLED UP AND CANNOT BE USED AGAIN. KINK WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2070776 | OPTICROSS 18 | CATHETER, ULTRASOUND, INTRAVASCULAR | OBJ | BOSTON SCIENTIFIC CORPORATION | H7493932800180 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |