(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.The other nc trek device referenced in describe event or problem is filed under a separate medwatch report number.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.The abbott internal recall number is 2024168-3/14/2017-002-r.
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It was reported that prior to use, when the protective sheath was removed from the nc trek devices, there was no balloon.The devices were not used.The patient was stented and did well.There was no clinically significant delay in the procedure.No additional information was provided.
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(b)(4).Return device analysis indicated that there was contrast in the inflation lumen which can indicate that the device was prepped with the sheath on.It should be noted coronary dilatation catheters (cdc), nc trek rx, global, instruction for use states: in step three to remove the protective sheath off the balloon before completing step four and five, which states prepare an inflation device with the recommended contrast medium according to the manufactures instructions and evacuate air from the balloon segment.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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