Model Number 9-PFO-030 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The results, method, and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that on (b)(6) 2021, a 30 mm amplatzer pfo occluder was selected for implant.During the implant procedure, when the device was being deployed, the distal disk presented in a bulbous deformation.The device was removed from the patient prior to detachment and was replaced with another product to resolve the event.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is stable.
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Manufacturer Narrative
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An event of distal disc presented in bulbous deformation was reported.One photo from the field, appeared to show distal disc deformed bulbously.However, the investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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