| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00786-1 |
| Product Name/Description |
AVVIGO + Multi-Modality Guidance System when used with OptiCross 18 Peripheral Imaging Catheter
Multiple product descriptions, material numbers, GTIN and serial numbers (see below)
ARTG 391872
(Boston Scientific Pty Ltd - Ultrasound system, imaging, cardiovascular) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/09/2024 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode.
Their investigation has determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter.
Note that the correct overlay display for this catheter is the 15-grid mark overlay, which allows for a reference depth setting of 14.9mm for peripheral catheters.
This software problem is limited to Live or Record mode. In Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled to the appropriate size.
No patient complications were reported as a result of this defect to date. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Boston Scientific recommends using the measurement tools, available in Review mode only, to take vessel measurements (refer to detailed instructions included within the AVVIGO+ Multi-Modality Guidance System Instructions for Use, IFU).
If measuring using grid mark overlay is preferred, it should only be performed in Review mode. Additionally, a physician can manually adjust the depth settings through the ‘Case Settings’ menu or elect to remove the grid marks from the display at time of use.
Boston Scientific is developing a software update to address this anomaly. |
| Contact Information |
02 8063 8340 - ANZ_Incident_Report@bsci.com - Boston Scientific Corporation |