Model Number 9-ASD-010 |
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 Date 11/20/2020 |
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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After having deployed an asd (amplatzer septal occlude) device in cobra shape, the physician has removed the delivery system and device out of the patient.Then he noticed the little kink at the tip of the delivery system.The physician change delivery systems, and was able to re-deploy the occluder without a deformation.Patient is stable.
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Manufacturer Narrative
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The reported event of the occluder deploying with a 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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