(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.
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It was reported there was strong resistance noted during removal of the protective sheath from the 3.75 x 15 mm nc trek balloon.When the protective sheath was removed, the device was almost broken in two parts at the proximal balloon seal; therefore, the nc trek could not be used.A new trek was used to complete the procedure successfully.There was no patient involvement.There was no clinically significant delay in the procedure.No additional information was provided.
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(b)(4).Visual inspection was performed on the returned device.The reported separation and difficulty removing the sheath were confirmed.The complaint investigation determined the reported difficulty was confirmed and the issue was determined to be 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 [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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