Catalog Number 1014256-020 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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Event Description
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It was reported that during device preparation, the armada 18 leaked during flushing.The device was not used and there was no patient involvement.There was no reported clinically significant delay in the procedure.Another armada 18 was used to complete the procedure.No additional information was provided.
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Manufacturer Narrative
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Internal file number: (b)(4).The device was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation was unable to determine a cause for the reported leak.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
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Search Alerts/Recalls
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