Model Number 9-ASD-010 |
Device Problem
Material Deformation (2976)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.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 10mm amplatzer septal occluder was selected for implant.During deployment, a cobra-like deformation was noted.The device was recaptured and exchanged for a 11mm amplatzer septal occluder and was successfully implanted.The patient was reported to be in stable condition.
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Manufacturer Narrative
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The reported event of deformation upon deployment 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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