Catalog Number UNKNOWN |
Device Problems
Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
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Patient Problem
No Information (3190)
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Event Date 11/25/2014 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Catalog number: unknown but referred to as a cook günther tulip filter.Since catalog number is unknown the 510(k) could be either k090140, k112119 or k121057.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 gunther tulip filter on (b)(6) 2014 (b)(4) and (b)(6) 2014 (b)(4).The filter was placed at the (b)(6) hospital in (b)(6)." patient outcome: unknown.Hospital and medical records have been requested but not yet provided.
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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.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 04/20/2016 as follows: plaintiff allegedly received an implant on (b)(6) 2014 due to a non-occlusive thrombus in left femoral vein resulting from being struck by a motor vehicle.Plaintiff is alleging that the filter was implanted in the wrong vein (i.E, the right iliac vein).Patient alleges successful retrieval on (b)(6) 2014 at which time another filter was implanted.
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Manufacturer Narrative
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Manufacturer reference # (b)(4).Exemption number e2016032.(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 ¿filter implanted in the wrong vein".Cook will reopen its investigation if further information is received warranting supplementation in accordance with 21 c.F.R.803.56.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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