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 10/20/2021 |
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 a 9mm amplatzer septal occluder(aso) was selected for an implant on (b)(6) 2021.The aso deformed into a cobra head shape during deployment.There was no interaction with atrial structures during deployment and the device was never release from the delivery cable.No angulation or kink noticed on the delivery system.A new 9mm amplatzer septal occluder was used to complete the procedure with no further issue.Patient stable, there is no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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Manufacturer Narrative
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The reported event of "the aso deformed into a cobra head shape during deployment" could not be confirmed.The investigation confirmed the device met visual and functional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.
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Event Description
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It was reported that a 9mm amplatzer septal occluder (aso) was selected for an implant on (b)(6), 2021.The aso deformed into a cobra head shape during deployment.There was no interaction with atrial structures during deployment and the device was never release from the delivery cable.No angulation or kink noticed on the delivery system.A new 9mm amplatzer septal occluder was used to complete the procedure with no further issue.Patient stable, there is no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
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Search Alerts/Recalls
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