| TGA Action ID |
RC-2025-RN-00665-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
WATCHMAN TruSeal Access System and WATCHMAN FXD Curve Access System
Material numbers: M635TS70010, M635TS70020, M635TS70040, M635TS80010, M635TS80020
GTIN numbers: 08714729965732, 08714729965749, 08714729965756, 00191506013820, 00191506013837
All unexpired batches |
| ARTG Number |
310680, 444930 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class I |
| Reason for the Action |
There has been an increased observation of air embolisms related to WATCHMAN procedures. The global rate of reported air embolism under any sedation type during a WATCHMAN procedure is 0.05% and associated with death in 0.006% of cases.
After a comprehensive investigation, it was concluded that these complaints are not associated with the design or manufacture of the WATCHMAN system. Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published literature and clinical data in percutaneous procedures requiring transseptal access to the left atrium when conscious or deep sedation is used, patients have an approximately three-times higher risk of negative left atrium pressure and air ingress. This risk is especially prevalent in patients with pre-existing low left atrial pressure, hypovolaemia, and partial upper airway collapse.
The WATCHMAN Access Systems Instructions for Use (IFUs) and WATCHMAN physician training will be updated to emphasise instructions related to Access System air management. This update will strengthen the information provided to clinicians regarding the potential for air embolism during WATCHMAN procedures performed under conscious or deep sedation and provide mitigation strategies. |
| Instructions for Customers/Users |
Customers are to review the updates related to air embolism, as detailed in Appendix 2 of the customer letter. These updates will be included in the WATCHMAN Access System IFUs and physician training.
These updates include strengthened warnings concerning patients under deep or conscious sedation being at increased risk of negative left atrial pressures. The most appropriate anaesthesia method should be based on individual patient characteristics. Additional caution should be used with patients under deep or conscious sedation, such as:
- ensuring the patient is not hypovolemic
- make device exchanges with the access system valve below the level of the heart or under fluid, and withdraw devices slowly until near the valve, then make exchanges during expiration. |
| Action Commencement Date |
12/08/2025 |
| Responsible Entity |
|
| Contact Information |
ANZ_Incident_Report@bsci.com - Boston Scientific |