Model Number 9-ASD-016 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/12/2022 |
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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It was reported that a 16mm amplatzer septal occluder was selected for an implant on (b)(6) 2022.The left atria disc deformed into cobra and was unable to implant.There was no angulation or kink noticed in the delivery system device was replace with a non abbott device.Patient stable, 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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Event Description
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It was reported that a 16mm amplatzer septal occluder was selected for an implant on (b)(6) 2022.The left atria disc deformed into cobra and was unable to implant.There was no angulation or kink noticed in the delivery system device was replace with a non abbott device.Patient stable, no additional information was provided.
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Manufacturer Narrative
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The reported event of a 16mm amplatzer septal occluder presenting cobra deformation 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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