Catalog Number 9-PFO-2518 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/08/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on (b)(6) 2024, a 18-25mm amplatzer talisman patent foramen ovale (pfo) occluder (lot: 8864459) was chosen for implantation utilizing an 8f amplatzer talisman delivery sheath.The delivery sheath was advanced into the patient anatomy.When attempting to connect the loader to and advance the occluder into the delivery sheath, air bubbles 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.No air entered the patient anatomy.The device was implanted successfully.There were no reported patient consequences and the patient remained hemodynamically stable throughout.There was no clinically significant delay.
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Manufacturer Narrative
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An event of air/gas in the device (air bubbles) was reported.A returned device assessment 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.Information from the field indicated that the delivery sheath was advanced into the patient anatomy.When attempting to connect the loader to and advance the occluder into the delivery sheath, air bubbles 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.No air entered the patient anatomy.The device was implanted successfully.The cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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