Model Number 9-ASD-022 |
Device Problem
Unintended Movement (3026)
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Patient Problem
Embolism (1829)
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Event Date 06/27/2019 |
Event Type
Injury
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Manufacturer Narrative
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Further information regarding this event has been requested.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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On (b)(6) 2019, a 22mm amplatzer septal occluder was selected for implant.During procedure the delivery system was taken into the left atrium and the device was released from the cable and embolized into the atrium.After several attempts to recover the device the patient was opened up to recover the occluder.The patient was reported to be in stable condition.
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Manufacturer Narrative
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An event of embolization was reported.The results of the investigation are inconclusive since 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 at the time of commercialization.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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