| TGA Action ID |
RC-2026-RN-00858-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
OptiCross Intravascular Ultrasound (IVUS) Imaging Catheters
OptiCross Coronary Imaging Catheter
Material Numbers: H749518100, H749518120
Opticross HD 60 MHz Coronary Imaging Catheter
Material Numbers: H74939352020, H74939352060
Opticross 6 HD 60 MHz Coronary Imaging Catheter
Material Numbers: H74939354060, H74939354100
OptiCross 18 30 MHz Peripheral Imaging Catheter
Material Number: H7493932700180
OptiCross 35 15 MHz Peripheral Imaging Catheter
Material Number: H7493932800350 |
| ARTG Number |
219096, 284348, 315943, 349490 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
Boston Scientific is updating the Instructions for Use (IFU) for the OptiCross family of intravascular ultrasound (IVUS) imaging catheters to revise the flushing instructions and reinforce device preparation and air-management practices. The update follows reports of air embolism, including events involving patient death, and repeated flushing to restore image quality while the catheter was positioned within the patient. The updated IFU will remove instructions permitting flushing while the catheter is positioned within the patient when entrapped air is suspected. |
| Instructions for Customers/Users |
Customers are to:
- Review IFU updates related to air embolism as detailed in the Customer Letter.
- Complete all device preparation and flushing instructions before inserting the catheter into the patient, including clearing air from accessories and completing all three prescribed flushing steps.
- Do not flush the catheter while it is positioned within the patient if entrapped air is suspected. Remove the catheter from the patient before performing any additional flushing. |
| Action Commencement Date |
30/10/2026 |
| Responsible Entity |
|
| Contact Information |
ANZ_Incident_Report@bsci.com - Boston Scientific |