Catalog Number UNKNOWN |
Device Problems
Difficult to Remove (1528); Malposition of Device (2616); Insufficient Information (3190)
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Patient Problems
Aspiration/Inhalation (1725); No Information (3190)
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Event Type
malfunction
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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).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) 2012." 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 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.Unknown as lot # is unknown.It has not been possible to investigate this event based on the limited information, and we are closing the report until further information is received.If additional information is received, the report will be re-opened for further investigation.
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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) 2012." 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 02/07/2017 as follows: the patient allegedly received the device implant on (b)(6) 2012 via common femoral vein as prophylaxis for pe following left thoracotomy with partial pericardiectomy and acute dvt.Anticoagulation was contraindicated at time of device placement.The patient is alleging tilt, device is unable to be retrieved, and breathing problems.
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Manufacturer Narrative
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Exemption number e2016032.William cook (b)(4) (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi) (importer).Manufacturer reference # (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 "tilt, unable to be retrieved, difficulty breathing.Updated sfc".Cook will reopen its investigation if further information is received.Unknown if the reported difficulty breathing is directly related to the filter and unable to identify a corresponding failure mode at this point in time.Filter tilt is a known risk in relation to filter implant reported in the published scientific literature and may occur during placement or during implanting period.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.This additional information was received on 02/07/2017 as follows: the patient allegedly received the device implant on 10/30/2012 via common femoral vein as prophylaxis for pe following left thoracotomy with partial pericardiectomy and acute dvt.Anticoagulation was contraindicated at time of device placement.The patient is alleging tilt, device is unable to be retrieved, and breathing problems.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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