Catalog Number 9-ASD-026 |
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 01/31/2024 |
Event Type
malfunction
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Event Description
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It was reported that a 26mm amlpatzer septal occluder was selected for implant on (b)(6) 2024 using an unknown abbott delivery system.During implant the device took on a cobra shape.The device was removed from the patient and replaced with a new 26mm amplatzer septal occluder.There were no interactions with cardiac structures.There were no angulations or kinks noted in the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.There were no adverse effects to the patient.The patient status was stable.
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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 could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.Additionally, images were received from the field and they appeared to show the device deformity in cobra shape.However, it could not be confirmed as there was no cobra shape deformity during the returned device analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.The cause of the reported incident 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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