(b)(4).Incorrect prep- flushed prior to attempted sheath removal.The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues.[medwatch # 2024168-2017-02310].
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It was reported that prior to sheath removal, the 3.25 x 15 mm nc trek dilatation catheter was flushed.Next, sheath removal was attempted, but could not be removed.Force was applied, but the sheath still could not be removed and the device was not used.A second nc trek dilatation catheter was then used without issue.No additional information was provided.
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(b)(4).Evaluation summary: the device returned for analysis.The complaint investigation determined the reported difficulty was related to manufacturing issues associated with the protective sheath.On march 14, 2017, abbott vascular decided to initiate a voluntary field action for some sizes and lots of the nc trek family of dilatation catheters for difficulty to remove sheath which may lead to inflation or deflation issues.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; thus, 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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