Boston Sci Expands Obsidio Correction to Include All GI Bleeding Embolization
Since the initial recall in Q124, the company has now updated its IFU barring the Obsidio from all GI bleeding embolizations after reports the aliquot technique resulted in high risk of bowel ischemia.
Boston Scientific has again updated the instructions for use (IFU) and use recommendations connected to its Q124 correction of the Obsidio Conformable Embolic after reporting two additional deaths and eight injuries connected to the issue.
The Obsidio Embolic is a premixed embolic agent delivered minimally invasively to block blood flow to specific blood vessels. After injected, the agent creates a solid cast in the vessel and stops blood flow to treat hypervascular tumors and to occlude blood flow in peripheral blood vessels that are bleeding or hemorrhaging.
Previously, Boston Scientific issued the February recall after determining that using the aliquot technique delivery method of Obsidio for lower gastrointestinal bleeding embolization had a high risk of bowel ischemia. The correction was then posted by FDA in April.
"When the aliquot technique is used, a small amount of the Obsidio Embolic is injected into a catheter, followed by a saline and/or contrast flush," a spokesperson from Boston Scientific told MD+DI, in April. "This is a technique that is performed by physicians in many clinical scenarios using a variety of embolics as it allows for continued use of the delivery catheter."
At the time, the company said it does not recommend “that the aliquot technique be used to deliver Obsidio Embolic for lower GI bleed embolization procedure and warned that doing so may prevent blood and oxygen flow to organs including the small bowel, or non-target embolization, which could lead to prolonged hospitalization, additional surgery need, or death,” MD+DI reported at the time.
The most common complications after using the aliquot technique with Obsidio, according to the initial recall, include the need to perform major surgery like bowel resection and diverting colostomy.
“Boston Scientific issued a product advisory in February 2024 recommending that physicians not use the aliquot technique when performing embolization for lower gastrointestinal bleeding with the Obsidio Conformable Embolic as dilution of the material may occur, which can alter the performance of the device,” a spokesperson said, at the time.
Now months after the initial correction, Boston Scientific, on Oct.11, has again updated its IFU for the device. In the updated instructions, the company says not to use the aliquot technique or push Obsidio with saline when performing embolization for any gastrointestinal bleeding. This is a departure from the February recall which stated not to use the technique for lower gastrointestinal bleeding embolization only.
Additionally, the updated IFU states that users should not make forceful injections in or near Obsidio as it could change the properties of the device and raise the risk of off-target embolization, and to follow the revised instructions included in the recommended procedure section of the labeling.
With the additional reports included, there have been 15 injuries, and four deaths related to the issue.
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