Model Number 9-ASD-010 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2021 |
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 10 mm amplatzer septal occluder was chosen for procedure.During the procedure, the user inserted the device and the device presented in a "cobra" shape.The device was removed and exchanged with a new 12, mm amplatzer septal occluder.The patient remained stable throughout the procedure and has been discharged.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.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Search Alerts/Recalls
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