AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM
Report
- Report Number
- 2124215-2024-62953
- Event Type
- Malfunction
- Date Received
- October 8, 2024
- Date of Event
- September 20, 2024
- Report Date
- December 20, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- DQK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D2B: PRO CODE (PRODUCT CODE): DQK, DSK, IYO, ITX.
D2B: PRO CODE (PRODUCT CODE): DQK, DSK, IYO, ITX .
THE PROCEDURE WAS CANCELLED. DURING INTRAVASCULAR ULTRASOUND (IVUS) OF A MILDLY CALCIFIED VESSEL, IMAGING ISSUES WERE EXPERIENCED WITH AN AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM AND OPTICROSS HD CATHETER. AN IMAGE FAILED TO APPEAR AND AN ERROR CODE DISPLAYED INDICATING A MOTOR DRIVE UNIT OVERLOAD ISSUE. THE DEVICE WAS RETRACTED WITH DIFFICULTY USING THE SLED AUTOMATED PULLBACK FEATURE AND THE CATHETER WAS FLUSHED. THE SAME ISSUE OCCURRED. UPON REMOVAL, THE DISTAL SHAFT OF THE CATHETER WAS KINKED. THE PROCEDURE WAS CANCELLED.
THE PROCEDURE WAS CANCELLED. DURING INTRAVASCULAR ULTRASOUND (IVUS) OF A MILDLY CALCIFIED VESSEL, IMAGING ISSUES WERE EXPERIENCED WITH AN AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM AND OPTICROSS HD CATHETER. AN IMAGE FAILED TO APPEAR AND AN ERROR CODE DISPLAYED INDICATING A MOTOR DRIVE UNIT OVERLOAD ISSUE. THE DEVICE WAS RETRACTED WITH DIFFICULTY USING THE SLED AUTOMATED PULLBACK FEATURE AND THE CATHETER WAS FLUSHED. THE SAME ISSUE OCCURRED. UPON REMOVAL, THE DISTAL SHAFT OF THE CATHETER WAS KINKED. THE PROCEDURE WAS CANCELLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 20183 | AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM | COMPUTER, DIAGNOSTIC, PROGRAMMABLE, COMPUTER, BLOOD-PRESSURE | DQK | BOSTON SCIENTIFIC CORPORATION | 0104031808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |