Catalog Number A35HPV12080080 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problems
Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
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Event Date 12/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: month and year valid.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that during a fistulogram, a fortrex device burst.The patient had a venotomy to remove the fragments of balloon but this was unsuccessful.The patient was admitted to hospital and taken for a repeat fistulogram the next day.The fragments from the fortrex balloon were in the subclavian vein near the proximal stent.A stent was used to cage the fragments to the patient's vessel wall.
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Manufacturer Narrative
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Additional information: burst occurred during balloon inflation in the great saphenous vein (gsv).If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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