Model Number 9-ASD-032 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/18/2021 |
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 the final report.
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Event Description
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It was reported a 32 mm amplatzer septal occluder and 12f mulin sheath were chosen for procedure.During the procedure the user attempted to position and deploy the device, however the device presented with cobra deformation.The device removed and exchanged with a new, 32mm non-abbott device.No additional information has been provided.
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Manufacturer Narrative
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The reported event of cobra deformation could not be confirmed.One video was received from the field, which appeared to show an occluder being deployed with a cobra deformation.However, the investigation confirmed the device met visual and 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 specifications.The cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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