Model Number 9-ASD-009 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2021 |
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 a subsequent submission.
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Event Description
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It was reported that on (b)(6) 2021, a 9mm amplatzer septal occluder was selected for implant using a 6f amplatzer torqvue delivery system.Upon deployment of the left atrial disc in the patient, the disc deformed into a cobra shape.The occluder was re-sheathed and removed from the patient.A new 9mm amplatzer septal occluder was successfully implanted.The patient was reported to be in stable condition.
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Manufacturer Narrative
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An event of the disc deforming in a cobra shape was reported.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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