(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not 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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It was reported that the procedure was to treat a lesion located in the 80% stenosed mid to distal right coronary artery.The guide wire crossed successfully followed by advancement of a 3.5 x 15 trek balloon catheter which was used for pre-dilatation of the mid to distal rca, respectively.A 4.0 x 18 mm xience prox stent was deployed.Post-dilatation was attempted with the a 3.5 x 15 mm nc trek; however, resistance was felt during advancement of the balloon catheter to the deployed stent and upon attempted inflation of the balloon it would not inflate.It was stated that there was some resistance felt during removal of the protective sheath prior to use of the nc trek balloon catheter in the patient and it was difficult to load the balloon catheter onto the guide wire.A new 3.5 x 15 mm nc trek was used for post dilatation with a very good result.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
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