Model Number 9-ASD-MF-025 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/23/2020 |
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 a subsequent submission.
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Event Description
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On (b)(6) 2020, a 25mm amplatzer cribriform occluder was selected for implant.During positioning, the right atrial disc formed in a bulbous shape and the occluder was removed from the patient.The occluder was deployed outside the patient, however the deformation persisted.A new 25mm amplatzer cribriform occluder was successfully implanted.No patient consequences were reported.
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Manufacturer Narrative
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The reported event of a round, bulbous 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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