Model Number 9-PDA-006 |
Device Problem
Material Deformation (2976)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
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Event Description
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On an unknown date, during the procedure a 9-pda-006 took on a unspecified shape.The device was replaced and procedure completed.The patient remained stable throughout the procedure.
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Manufacturer Narrative
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The reported event of an amplatzer duct occluder deforming and not taking the usual shape 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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