Catalog Number AB35W08060080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Stenosis (2263)
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Event Date 01/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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During the index procedure one in.Pact admiral paclitaxel eluting balloon catheter was used to treat the swing point of the left arm.Approximately 2 months post index procedure the patient suffered from excessive bleeding from fistula post dialysis.The event was described as avf stenosis and repair.Fistulogram corrected the issue.A fistulogram was performed and the swing point was treated with a non mdt pta.The patient recovered.The investigator reported that the event is not related to the index device, procedure or paclitaxel.
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Manufacturer Narrative
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Device used during index procedure was a medtronic admiral xtreme standard pta balloon catheter.Sponsor assessed the event is not related to the index device, procedure or paclitaxel.The revascularization to treat the event was carried out (18 jan 2018).Cec adjudicated the event as not related to the procedure, device or therapy and the revascularization as clinically driven target lesion revascularization.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information: an evercross balloon was used during index procedure.Lot number provided.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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