Model Number 9-ASD-MF-025 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 a 25mm amplatzer cribriform occluder was reported faulty on an unknown date.Device became malformed when it was deployed across the septum.The right atrial (ra) disc took on a bulbous shape, rather than lying flat against the septum.The device was recaptured and an alternative was implanted.Cause unknown.There are no details of which replacement device was used.Patient status is unknown and no addition information was provided.
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Manufacturer Narrative
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An event of bulbous deformation 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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