Important Safety Alerts

Medical device manufacturer, SIS Medical AG, has issued a medical device safety alert concerning its OPN NC Super High Pressure PTCA Balloon:

• Article Number [REF]: 150-010-004, 150-015-004, 150-020-004, 200-010-004, 200-015-004, 200-020-004, 250-010-004, 250-015-004, 250-020-004, 300-010-004, 300-015-004, 300-020-004, 350-010-004, 350-015-004, 350-020-004, 400-010-004, 400-015-004, 400-020-004, 450-010-004, 450-015-004, 450-020-004
• Lot Number: All

This notification is to inform users about a change to the Rated Burst Pressure (RBP) of the OPN NC Super High Pressure PTCA Balloon. As part of continuous improvement efforts, the manufacturer has increased its internal requirements by applying higher standards for the declaration of the RBP for the OPN NC balloon. As a result, the manufacturer is voluntarily, with immediate effect, reducing the RBP for the OPN NC Super High Pressure PTCA balloon from 35 atm to 32 atm.

The most common potential consequence related excessive pressurization is a balloon burst that leads to a prolonged procedure while the device is exchanged. The most severe consequence would be an embolism in a coronary vessel. There have been no patient harms reported related to this issue.

As a result of the change in RBP, the Compliance data are updated. The following is an overview of Compliance data for each balloon diameter at 32 atm:

According to the manufacturer, it is advised that use of the OPN NC Super High Pressure PTCA balloon can be continued at 32 atm RBP.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the products, please contact your supplier for necessary actions.

Posted on 10 November 2020