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Health Sciences Authority
Dear Healthcare Professional Letters

Potential Y-90 microsphere leakage with specific lots of TheraSphere™ administration sets due to unsecure connection between outlet luer and patient catheter

Audiences

Healthcare professional

Industry member

Product type

Medical devices

2 August 2021

This article has been migrated from an earlier version of the site and may display formatting inconsistencies.

A Dear Healthcare Professional Letter has been issued by Boston Scientific to inform healthcare professionals of the potential leakage of Yttrium-90 (Y-90) microspheres with specific lots of TheraSphere™ administration sets due to unsecure connection between the outlet luer of the administration set and the patient catheter. If the leakage of Y-90 microspheres occurs, the patient may receive a lower than intended TheraSphere™ dose but no patient harm is expected. In addition, TheraSphere (Y-90) leakage might expose the patient and users to radiation. However, the level of radiation exposure to the skin is estimated to be within regulatory limits and no serious harm is anticipated. Healthcare professionals are advised to follow the existing administration set assembly instructions within the Instructions for Use (IFU) to ensure a firm connection is made between the outlet luer and the patient catheter prior to and during TheraSphere™ administration. Please refer to the letter for details.

Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg (opens in new tab) and follow the procedures below to access the MOH Alert system.

Step 1: Select your profession under ‘For Healthcare Professionals’.

Step 2: Click on ‘Useful links’.

Step 3: Click on ‘MOH Alert’ and log in via Singpass.

Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.