Catalog Number ZTEG-2PT-32-200-PF-D |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Name and address for importer site: (b)(4).Similar to device under 510(k): p070016.Investigation is still in progress.
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Event Description
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Description of event according to initial reporter: the device was to be used as an emergency treatment for the ruptured dissecting aortic aneurysm.When the physician flushed the complaint device prior to patient contact, massive amount of fluid leaked from the hemostatic valve.Since air could not be fully expelled due to the leakage, another cook's txd- was used instead.Patient outcome: there have been no adverse effects reported.
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Event Description
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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Exemption number e2016032.William cook europe aps (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturers ref# (b)(4).Name and address for importer site: cook medical incorporated (cmi) (b)(4).Registration no.: (b)(4).Summary of investigational findings: as per the reported information, leak from the hemostatic valve was observed when flushing during preparation.The device was replaced with another device prior to use.No adverse effects to the patient have been reported.Since no product was returned, it would be inappropriate to speculate at what may or may not have occurred based on the limited information made available to us.Not enough information is provided to conclude on a most likely root cause.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Search Alerts/Recalls
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