Catalog Number IGTCFS-65-FEM |
Device Problems
Difficult to Remove (1528); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problems
Chest Pain (1776); Tachycardia (2095); Anxiety (2328); No Information (3190)
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Event Type
malfunction
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Manufacturer Narrative
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No information regarding the event was provided.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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It is alleged that the patient received a gunther tulip on (b)(6) 2009.It is alleged that the patient 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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Blank fields on this form indicate the information is unknown, or unavailable.Investigation - evaluation.Investigation is reopened due to additional information provided.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 'tulip: unable to retrieve, tachycardia, chest pain, anxiety'.Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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 pain/discomfort is directly related to the filter.Unknown if the reported tachycardia, anxiety is directly related to the filter and unable to identify corresponding failure mode(s) at this time.No relevant notes found on work order or device lot.No other complaints on lot.Product 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 is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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 provided at this time.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable, or unchanged.Additional information patient code: chest pain (1776), not listed in ifu.Tachycardia (2095), not listed in ifu.Anxiety (2328), not listed in ifu.Device code: difficult to remove (1528), not listed in ifu.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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Event Description
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Patient allegedly received an implant on (b)(6) 2009 via venous access due to right lower leg deep vein thrombosis (dvt) and bilateral pulmonary embolism (pe).Patient alleges device is unable to be retrieved, tachycardia, noncardiac chest pain.Patient further alleges anxiety.
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Search Alerts/Recalls
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