Model Number 9-ASD-MF-025 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2022 |
Event Type
malfunction
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Event Description
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It was reported that a 25mm amplatzer cribriform occluder was selected for implant on (b)(6) 2022.During procedure, after deployment, both discs were puffy and deformed that appeared bulbous in shape and the device was removed from the patient prior to release from the delivery cable.There was no interaction with atrial structures during deployment and no angulation or kink noticed in the delivery system.A new 25mm amplatzer cribriform occluder was selected successfully implanted.No patient consequences were reported.No additional information was provided.
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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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Manufacturer Narrative
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An event of a bulbous deformation was reported.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 defined manufacturing specifications.The cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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