Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its TheraSphere Administration Sets [Product Code: OTT-SPE-FP-226 (990226.SPE), OTT-SPE-FP-001 (990264.SPE); Lot: 001E, 002E, 004E, 005E, 006E, 007E, 114E, 690E, 692E, 61673698, 61673699, 61673700, 61673702, 61694124, 61705932, 61706656, 61705933, 61732176; Expiration Date Range: 5 Aug 2021 - 15 Dec 2021, 21 Aug 2021 - 30 Nov 2021].
The manufacturer has received complaints of leaks and loosening at the patient catheter connection. Their investigation has determined that the outlet luer could loosen after being fastened to the patient catheter. This could result in an unsecure connection to the patient catheter, which may result in the leakage of Yttrium-90 (Y-90) microspheres from this connection. If leakage of Y-90 microspheres occurs, the patient may receive a lower than intended TheraSphere dose.
TheraSphere (Y-90) leakage might expose the patient and users to radiation. According to the manufacturer, an unlikely and prolonged skin exposure could result in reddening or sunburn-type symptoms of the skin which would resolve without medical intervention.
Users are advised to continue to follow the Instructions for Use to ensure a firm connection is made between the outlet luer and the patient catheter prior to, and during, TheraSphere administration.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Jul 2021