(b)(4).The additional nc trek devices are being filed under separate medwatch reports.Evaluation summary: the device returned for analysis.The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath.Abbott vascular performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.The root cause identification was complicated by the fact that users were describing multiple symptoms when reporting the complaints.To date, the frequency of worldwide reported events for difficulties removing the protective balloon sheath, inflation and deflation has reached an actionable limit.Abbott vascular communicated the voluntary field action to the fda on march 17, 2017 [medwatch # 2024168-2017-02310].Corrective action has been implemented per site operating procedures.The product will continue to be trended.The abbott internal recall number is 2024168-3/14/2017-002-r.
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Reportedly, there was an issue with three nc trek balloon dilatation catheters; however, there was no information available.No adverse patient effects were reported.No additional information was provided.The return device analysis of the three nc trek catheters found the following: the 3.5x8mm nc trek: the outer member was stretched and torn at the proximal seal.The 3.75x12mm nc trek: the outer member was stretched at the proximal seal.The 2.75x20mm nc trek: the hypotube was separated.
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