Catalog Number ECH060040A |
Device Problem
Occlusion Within Device (1423)
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Patient Problem
Thrombus (2101)
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Event Date 10/03/2014 |
Event Type
Injury
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Event Description
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On (b)(6) 2014, a patient was implanted with a gore® acuseal vascular graft for arteriovenous access.The dialysis center reported to gore that on (b)(6) 2014, the graft clotted when cannulated with a 15g needle in the medial aspect of the left lower arm on the arterial side of the gore® acuseal vascular graft.The graft is currently open and able to be dialized.
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Event Description
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The graft is still implanted but the clots have been removed and it is difficult to dialyze the patient through the graft.
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Manufacturer Narrative
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Results: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Conclusions: the device remained implanted; consequently, a direct product analysis was not possible.Without additional information it is impossible to further investigate this event.
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Search Alerts/Recalls
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