Catalog Number UNKNOWN |
Device Problems
Migration or Expulsion of Device (1395); Insufficient Information (3190)
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Patient Problems
Chest Pain (1776); Dyspnea (1816); 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).Pma 510(k): 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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Exemption number e2016032.(b)(4).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, diff.To retrieve, migration, sob, chest pain'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Filter retrieval is occasionally difficult.This is well-known from published scientific literature where filter retrievals are referred to as simple vs.Complex.Several case reports published in scientific literature describe complex cases with successful endovascular filter retrievals using additional, advanced techniques.Unknown if the reported sob, chest pain is directly related to the filter.Rpn and lot# are unknown, but the celect filter is manufactured and inspected according to specifications.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.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Manufacturer Narrative
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Exemption number e2016032.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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This additional information received on 08feb2018 as follows: pt allegedly received an implant on (b)(6) 2014 via the right common femoral vein due to bilateral pulmonary embolism (pe), contraindication to anticoagulation.Pt is alleging migration.Pt is further alleging shortness of breath and chest pains.Attempted retrieval on (b)(6) 2015.
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Manufacturer Narrative
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Exemption number e2016032.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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Device explanted successfully on (b)(6) 2015.
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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.Cook medical incorporated (cmi) 400 daniels way bloomington, in 47404 registration no.: 3005580113.Additional information: investigation- cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.Manipulation in the area of the filter implant may cause migration or contribute to changes in the filter configuration and placement.Unknown if the reported pain/discomfort or shortness of breath (sob) is directly related to the filter.Catalog and lot# are unknown, but the celect filter is manufactured and inspected according to specifications.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.Blank fields on this form indicate the information is unknown or unavailable, or unchanged.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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