Catalog Number IGTCFS-65-1-JUG-TULIP |
Device Problems
Difficult to Remove (1528); Insufficient Information (3190)
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Patient Problems
Anxiety (2328); No Information (3190)
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Event Date 05/13/2011 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog #: unknown but referred to as a cook günther tulip filter.Expiration date: unknown as lot # is unknown.Mfr date unknown as lot # is unknown.Investigation is still in progress.
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Event Description
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Description according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2010." 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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(b)(4).Catalog #: unknown but referred to as a cook günther tulip filter.Expiration date: unknown as lot# is unknown.Mfr date unknown as lot # is unknown.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 according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2010." 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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(b)(4).According to device history records, based on the lot number provided, there is no evidence to suggest that this device was not manufactured according to specifications or that the filter did not perform as intended, e.G., the prevention of recurrent pulmonary embolism (pe) via placement in the vena cava in the situations described in the ifu.It has not been possible to fully investigate or evaluate this 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 according to short form complaint filed: it is alleged that "[pt] received a gunther tulip filter on (b)(6) 2010".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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(b)(4).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 was received on 12/05/2016 as follows: the plaintiff allegedly received the device implant via right interior jugular vein on (b)(6) 2010 due to trauma.An unsuccessful retrieval attempt allegedly occurred on (b)(6) 2011.The plaintiff alleges device is unable to be retrieved and anxiety.
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Manufacturer Narrative
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(b)(4).Corrected data based on new information received: adverse event to product problem, serious injury to malfunction.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 "an unsuccessful retrieval attempt allegedly occurred on (b)(6) 201, the plaintiff alleges device is unable to be retrieved and 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.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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