FDA Adverse Event
Malfunction
Summary report: N
AVVIGO?+
MDR report key: 24254519
·
Received February 3, 2026
Report
- Report Number
- 2124215-2026-06246
- Event Type
- Malfunction
- Date Received
- February 3, 2026
- Date of Event
- January 13, 2026
- Report Date
- March 18, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQK
- UDI-DI
- 00191506033163
- PMA / PMN Number
- K230884
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D2B, PRO CODE (PRODUCT CODE), DSK, ITX, IYO.
Additional Manufacturer Narrative · 0
D2B, PRO CODE (PRODUCT CODE), DSK, ITX, IYO.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN AVVIGO MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE. DURING THE CASE THE SYSTEM WOULD NOT "GO LIVE". THE PROCEDURE WAS CANCELED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN AVVIGO MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE. DURING THE CASE THE SYSTEM WOULD NOT "GO LIVE". THE PROCEDURE WAS CANCELED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142895 | AVVIGO?+ | COMPUTER, DIAGNOSTIC, PROGRAMMABLE | DQK | BOSTON SCIENTIFIC CORPORATION | H7492493120I0 | 0104728136 | 00191506033163 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |