Model Number 9-PFO-2518 |
Device Problem
Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2023 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2023, a 25-18mm amplatzer talisman pfo occluder was chosen for implant, using amplatzer trevisio intravascular delivery system (9-atv09f45/80).During the procedure, the device came off of the cable before the physician was ready to deploy it.Device was in the proper position and was being analyzed for deployment.The device stayed in its current position on the septum.The device was agreed to be safe and in a secure position.The physician stated that the device premature detachment was possibly due to cable manipulation.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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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.Na.
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Manufacturer Narrative
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An event of premature separation 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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Search Alerts/Recalls
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