Catalog Number UNKNOWN |
Device Problem
Insufficient Information (3190)
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Patient Problems
Perforation of Vessels (2135); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog#: unknown but referred to as a cook celect filter.Name and address for importer site: (b)(4).Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(b)(4).It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating ¿celect filter implanted".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.
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Event Description
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Description of event according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2014".Patient outcome: it is alleged that [pt] was injured without further explanation.Hospital and medical records have been requested but not yet provided.
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Manufacturer Narrative
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Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).Name and address for importer site: (b)(4).Corrected data based on new information received: adverse event to adverse event and product problem.Serious injury to malfunction.The event is currently under investigation.A supplemental report will be provided upon conclusion.
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Event Description
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This additional information received on 29/dec/2017 as follows: patient received an implant on (b)(6) 2014 via the right internal jugular vein due to deep vein thrombosis.Patient is alleging vena cava perforation due to the device.
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Manufacturer Narrative
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Manufacturer reference # (b)(4).Exemption number e2016032.(b)(4).It has not been possible to further investigate or evaluate this alleged event based on the limited information provided to date via the operative note stating 'celect, vc perforation'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Vena cava wall perforation is a known potential complication of vena cava filters.Both symptomatic and asymptomatic events have been reported.Among other causes, vena cava wall perforation may inadvertently be initiated by improper deployment, excessive force or manipulations near an implanted filter (e.G., a surgical procedure in the vicinity of a filter) and (or) procedures that involve other devices being passed through an in situ filter.There is a current debate in the published scientific literature on a differentiation between ivc wall perforation with and without clinical sequelae.E.G.Filter legs may be outside the contrast lumen on imaging without actually perforating the ivc wall (known as tenting) and with no clinical sequelae.In contrast, perforation of adjacent organs is reported with clinical sequelae.No evidence to suggest that this device was not manufactured according to specifications and nothing indicates that the filter did not perform as intended, e.G.Intended for the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava.
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Search Alerts/Recalls
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