Catalog Number 510038SIM1 |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 05/12/2022 |
Event Type
malfunction
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Event Description
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A notivisa website nº 2022.05.005309 report alleges that during a thoracoabdominal aortic endoprosthesis procedure, a catheter tip detached within the patient.No additional information has been received.
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Manufacturer Narrative
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The suspect device will not be returning for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.
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Manufacturer Narrative
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The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
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Search Alerts/Recalls
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