It was reported that on (b)(6) 2024, 25-18mm amplatzer talisman patent foramen ovale (pfo) occluder was chosen for implant, using 08f amplatzer talisman delivery sheath.During preparation, when pushing the device forward, air repeatedly appeared in the loader.Only when all connections, from the sheath to the loader, from the loader to the hemostasis valve and the hemostasis valve were submerged in a water bath, could the device be advanced without bubbles.The device was implanted with no further complication.The patient remained hemodynamically stable throughout the procedure.This issue reportedly caused a clinically significant delay, but the delay did not result in adverse patient sequelae.
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An event of air while loading the occluder into the delivery sheath was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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