Catalog Number UNKNOWN |
Device Problems
Difficult to Remove (1528); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 06/08/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Lot#: unknown as information was not provided.Catalog#: unknown but referred to as a cook celect filter.Expiration date: unknown as lot# is unknown.Since catalog# is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.Mfr date: unknown as lot# is unknown.(b)(4).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 cook celect filter on (b)(6) 2015".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 number: unknown but referred to as a cook celect filter.Since catalog number is unknown the 510(k) could be either k061815, k073374, k090140, k112119, k121057 or k121629.(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 according to short form complaint filed: it is alleged that "[pt] received a cook celect filter on (b)(6) 2015." 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 received on 01/20/2017 as follows: plaintiff allegedly received an implant on (b)(6) 2015 via the due to traumatic spine injury followed by a major dvt.Plaintiff alleges that an attempted retrieval took place on (b)(6) 2015 where multiple attempts to retrieve the filter with snare were made to no success.Procedure notes state that an extra "retrieval was attempted using a glidewire and a long mpa catheter, however while advancing down to the left common iliac vein the patient experienced quite a bit of pain and the procedure was terminated." plaintiff is alleging device is unable to be retrieved.
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Manufacturer Narrative
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Exemption number (b)(4).Manufacturer reference # (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, unable to retrieve'.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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