Catalog Number UNKNOWN |
Device Problems
Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Perforation of Vessels (2135); Blood Loss (2597); No Information (3190); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Catalog# is unknown but referred to as cook celect filter.(b)(4).It has not been possible to investigate or evaluate this alleged event based on the limited information provided to date.Cook will reopen its investigation if further information is receiving 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) 2008".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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Event Description
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No additional information provided at this time.
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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).Name and address for importer site: cook medical incorporated (cmi).400 daniels way.Bloomington, in 47404.Registration no.: 3005580113.Investigation: 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, bleeding (internal) (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.Catalog and lot# are unknown, but the celect filter is manufactured and inspected according to manufacturing instructions.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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Event Description
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This additional information received on 16may2018 as follows: pt allegedly received an implant on (b)(6) 2008 via the right common femoral vein due to deep vein thrombosis.Pt alleges bleeding (internal).
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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).F10) patient code: blood loss (2597)-not listed in the ifu.G1) name and address for importer site: cook medical incorporated (cmi), 400 daniels way, bloomington, in 47404, registration no.: 3005580113.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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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Manufacturer Narrative
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Patient code(s): no code available (3191): internal bleeding.Device code(s): appropriate term/code not available (3191) was selected for the alleged device perforation.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information become available.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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Event Description
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Additional information received.Patient further alleges vena cava perforation and states "internal bleeding.Multiple strut perforations of the vena cava.".
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Manufacturer Narrative
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Investigation is reopened due to additional information provided.The reported allegations have been further investigated based on the information provided to date.Per quality engineering review, the additional information provided for this complaint does not change the previous investigation conclusion.Therefore, no new investigation activities will be conducted at this time.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.This report includes information known at this time.A follow-up medwatch report will be submitted if additional relevant information become available.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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Event Description
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No additional information has been provided at this time.
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Search Alerts/Recalls
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