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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Unspecified Infection (1930); Ischemia (1942); Pain (1994); Thrombosis (2100); Stenosis (2263); Pseudoaneurysm (2605)
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Event Type
Injury
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Manufacturer Narrative
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A complaint investigation was not able to be performed as no product code, lot number, or sample was provided.A review of complaints was performed and there have not been any similar reports related to a device malfunction.Review of capa log shows none initiated for this issue.Review of recall folder reveals none initiated for this type of event.Per the article, mid-term follow up results demonstrate patency rates comparable with those of the synthetic avf.The rate of complications, although slightly higher than that with traditional synthetic avf, is still acceptable in this population with no option for access.
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Event Description
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Received an article titled "early results of brachial arterio-arterial prosthetic loop (aapl) for hemodialysis." the article was to report results using the brachial synthetic arterio-arterial loop, which has been used in a significant number of patients with reasonable follow up.Per the article adverse events included: thrombosis, stenosis, ischaemia, infection, pseudoaneurysm, pain and distal edema.
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Search Alerts/Recalls
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