Model Number 9-PDA-005 |
Device Problem
Material Deformation (2976)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2020, a 5mm amplatzer duct occluder was selected for implant.During deployment, a cobra deformation was noted.The device was re-sheathed and removed and exchanged for another 5mm amplatzer duct occluder.The patient was reported to be in stable condition.
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Manufacturer Narrative
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The reported event of cobra deformation during device deployment not be confirmed.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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