Model Number 9-ASD-016 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2020 a 16mm amplatzer septal occluder was selected for a procedure.During procedure the device formed an s shape and the device was removed.The procedure was successfully ended by implanting a different device.There was no clinically significant delay in the procedure and the patient remained stable through out and post procedure.
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Manufacturer Narrative
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The reported event of the device deploying in an "s" shape could not be confirmed.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.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 event could not be conclusively determined.
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Search Alerts/Recalls
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