Catalog Number 9-ASD-MF-025 |
Device Problem
Difficult to Fold, Unfold or Collapse (1254)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that a 25mm amplatzer septal occluder was selected for implant on (b)(6) 2023 using an 8f amplatzer trevisio intravascular delivery system.During implant it was noted that both discs of the device took on a bulbous shape.There were no interactions with cardiac structures nor were there any angulations or kinks in the delivery system.
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Manufacturer Narrative
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An event of device deformity was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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Search Alerts/Recalls
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