Model Number 9-ASD-MF-030 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/26/2020 |
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 30mm amplatzer cribiform device was selected for a procedure.During deployment the left disc was not deployed well.The procedure was completed by using a different device.The patient remained stable through out and post procedure.There was no clinically significant delay in the procedure.
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Manufacturer Narrative
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The reported event of a deformed deployment was confirmed.Following the simulated deployment, the bulbous shape returned to normal and met 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 defined manufacturing specifications.A capa was initiated for further investigation and did not identify a product quality issue.However, corrective actions to further enhance performance are being pursued per internal operating procedures.
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Search Alerts/Recalls
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