| TGA Action ID |
RC-2025-RN-00710-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Heartstring III Proximal Seal System (HS III Seal)
Product Codes: HS-3045, HSK-3038, and HSK-3043
All Unexpired Lots
Manufacturing Dates: March 7, 2024 - Present |
| ARTG Number |
158121 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Three primary failure modes have been identified with the Heartstring III Proximal Seal System.
1. Failure of the Heartstring Seal to Load - applies to any malfunction that occurs during the four-step loading process, the visual inspection of a loaded HS III Seal, or unlocking the Delivery Device upon successful completion of the loading steps.
2. Failure of the Heartstring Seal to Deploy into the aortotomy - applies to any malfunction of the HS III Seal and/or Delivery Device from the time it is successfully unlocked to once complete delivery into the aortotomy and and all content of the Proximal Seal have exited the Delivery Device.
3. Failure of the deployed Heartstring Seal to provide adequate hemostasis - applies to any malfunction after a successfully deployed HS III Seal that does not adequately control bleeding at the anastomotic to allow the surgeon to perform suturing of the anastomosis.
The risk to patients varies depending on the failure, ranging from a minor surgical delay to tissue damage, bleeding, or embolic events. The complaint rates for these failures are 0.386% (failure to load), 0.135% (failure to deploy) and 0.042% (failure to provide adequate haemostasis). |
| Instructions for Customers/Users |
Customers should follow the instructions in the IFU and customer letter to avoid/minimise the failures.
Surgeons should always have a second HS III Seal available to replace a failed device, as per the IFU. If one of the above failures is encountered and persists, the HS III Seal should be removed, and a second HS III Seal should be loaded and deployed. Alternatively, if the surgeon's preference or the situation does not allow for use of a replacement HS III Seal, place a partial occlusion clamp on the aorta, isolating the aortotomy, and perform the anastomosis per traditional surgical technique.
The root cause and corrective actions to address these 3 failures are still under investigation. Customers will be notified once any corrective actions have been identified via a subsequent market action. |
| Action Commencement Date |
26/08/2025 |
| Responsible Entity |
|
| Contact Information |
1800 438 464 - Getinge Customer Service |