Starting from 1 January 2022, safety alerts related to medical devices not listed under MDACS that have potential serious health risk/ public health risk to local population are listed below.
The Department of Health (DH) today (March 16) drew users’ attention to the adverse event reports related to the Abbott Vascular Perclose ProStyle Suture-Mediated Closure and Repair System (the ProStyle) [Catalogue No.: 12773-02].
DH received seven adverse event reports related to foot separation events over the period of December 2021 to March 2023. DH immediately launched investigations and contacted the local supplier of the concerned device. According to the investigation reports provided by the manufacturer, the majority of the adverse events appeared to be related to the challenging anatomical conditions of the patient or related to the circumstances of the procedure.
According to the device’s Instructions for Use (IFU), the safety and effectiveness of the ProStyle device has not been established in patients with femoral artery calcium which is fluoroscopically visible at access site. The IFU also contains warnings related to the foot and breakage and advice on proper procedures to decrease the risk of foot breakage. According to the manufacturer, if the foot of the ProStyle device was to break off and become an embolic material, the foot would travel to the most distal aspect of the patient’s leg where the device was deployed. The foot could potentially cause a distal occlusion within that vessel that may require further medical or surgical intervention. Since the foot is radiolucent, it would be difficult to attempt to locate the foot with fluoroscopy, and an alternative imaging devices such as ultrasound maybe more appropriate.
The device is not currently listed under the Medical Device Administrative Control System.
Users of medical devices are reminded to take note of the limitations associated with the use of the device, and use the device in accordance with the manufacturer’s advice and the device’s IFU. In cases of doubt, users should contact their local supplier for details.
If you are in possession of the affected products and identified similar incident related to the device, please submit adverse event report to the Medical Device Adverse Event Reporting System: https://www.mdd.gov.hk/en/mdacs/report-adverse-events/index.html
Taking reference to the recommendations of the Global Harmonization Task Force and the International Medical Device Regulators Forum, the MDACS established a Medical Device Adverse Event Reporting System to collect and conduct analysis on information related to adverse event for early detection of safety signals so as to protect the health of patients and users of medical device. An adverse event report is not a conclusion that the device(s) caused or contributed to the adverse event.
Posted on 16 Mar 2023