ANGIOJET? SOLENT? OMNI
Report
- Report Number
- 2124215-2025-14855
- Event Type
- Malfunction
- Date Received
- March 27, 2025
- Date of Event
- February 28, 2025
- Report Date
- May 9, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DXE
- UDI-DI
- 08714729889663
- PMA / PMN Number
- K111182
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B - PRO CODE (PRODUCT CODE): KRA.
D2B - PRO CODE (PRODUCT CODE): KRA. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE REVEALED MULTIPLE SHAFT KINKS AND BUCKLING OF THE OUTER SHAFT. MICROSCOPE EXAMINATION REVEALED A HYPOTUBE SEPARATION WAS OBSERVED LOCATED AT 1 CM FROM THE TIP ALONG WITH SHAFT BUCKLING, STRETCHING AND KINKS. NO OTHER ISSUES WERE IDENTIFIED WITH THE DEVICE.
IT WAS REPORTED THAT CATHETER BREAK OCCURRED. AN ANGIOJET SOLENT OMNI WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. DURING WITHDRAWAL, IT WAS NOTED THAT A CATHETER BREAK OCCURRED. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT CATHETER BREAK OCCURRED. AN ANGIOJET SOLENT OMNI WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. DURING WITHDRAWAL, IT WAS NOTED THAT A CATHETER BREAK OCCURRED. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2530087 | ANGIOJET? SOLENT? OMNI | CATHETER, EMBOLECTOMY | DXE | BOSTON SCIENTIFIC CORPORATION | 109681-001 | 0035141565 | 08714729889663 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |