FDA Adverse Event
Malfunction
Summary report: N
AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM
MDR report key: 23791010
·
Received December 12, 2025
Report
- Report Number
- 2124215-2025-90647
- Event Type
- Malfunction
- Date Received
- December 12, 2025
- Date of Event
- November 17, 2025
- Report Date
- February 18, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQK
- UDI-DI
- 00191506040482
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
D2B PRO CODE: DSK.
Additional Manufacturer Narrative · 0
D2B PRO CODE: DSK. CORRECTION TO TAB E: INITIAL REPORTER INFORMATION.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE GRID MEASUREMENT WAS INCORRECT. AN AVVIGO PLUS IMAGING SYSTEM WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. IT WAS NOTED THAT THE GRID DISPLAY WAS NOT UPDATING CORRECTLY. THE DEVICE WAS STILL USED TO TAKE MEASUREMENTS OF THE TARGET LESION. THERE WERE NO PATIENT COMPLICATIONS.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE GRID MEASUREMENT WAS INCORRECT. AN AVVIGO PLUS IMAGING SYSTEM WAS SELECTED FOR ULTRASOUND EXAMINATION OF THE TARGET LESION. IT WAS NOTED THAT THE GRID DISPLAY WAS NOT UPDATING CORRECTLY. THE DEVICE WAS STILL USED TO TAKE MEASUREMENTS OF THE TARGET LESION. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154614 | AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM | COMPUTER, DIAGNOSTIC, PROGRAMMABLE, COMPUTER, BLOOD-PRESSURE | DQK | BOSTON SCIENTIFIC CORPORATION | 0106123705 | 00191506040482 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |