WILLIAM COOK EUROPE GUNTHER TULIP NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTER SET; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
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Catalog Number IGTCFS-65-1-UNI-TULIP |
Device Problems
Material Perforation (2205); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 03/22/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Expiration date: unknown as lot # is unknown.Similar to device under 510(k): k090140.Mfr date unknown as lot # is unknown.Investigation is still in progress.
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Event Description
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Description of event according to initial reporter: "i don¿t like the new filter system for 2 reasons: it is hard to get the filter into the sheath and secondly, when the filter is deployed, the release mechanism causes the filter to tilt.Today i could get the filter into the sheath with some difficulty but as it was passing through the neck into the jugular vein, it got stuck and as i was trying to retrieve it, one of the tynes perforated the sheath.Fortunately i got it out and inserted a central line to keep access available." (b)(4)."i have to say, i have also experienced difficult with the new cook retrievable ivc filter delivery system.Difficult to load for jugular delivery without damaging filter or introduce into delivery sheath without again damaging either filter or sheath.Pitty, because i really liked the old delivery method.The pictorial display in rad office is very unhelpful as is instructions in packet." (b)(4).Patient outcome: no adverse events related to the study procedure or the device, and no secondary interventions have been reported for this patient.
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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 ref# (b)(4).Summary of investigational findings: evaluation is based on customers description of event and returned product.According to the complaint report, "i could get the filter into the sheath with some difficulty but as it was passing through the neck into the jugular vein, it got stuck and as i was trying to retrieve it, one of the tynes perforated the sheath".The blue sheath with the long dilator has been returned.The returned appears a bit twisted.There is a mark on the sheath ~21 cm from the fitting.Two penetrations are found at ~26 cm and ~30cm from the fitting.Based on the returned, difficult approach is suspected to have caused the incident.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 cook medical will continue to monitor for similar events.
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Search Alerts/Recalls
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