It was reported that the procedure was to treat an unspecified coronary artery.During loading of the 2.5 x 12 mm xience alpine stent delivery system (sds) onto the guide wire, at about 30-50 cm in, the guide wire exited the side of the sds shaft before reaching the guide wire exit notch.The sds did not go into the anatomy.The device was removed from the guide wire and a new stent delivery system was used to complete the case.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
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(b)(4).Evaluation summary: (b)(4).The device was returned for analysis.The tear in the balloon was able to be confirmed.Based on a visual and functional inspection of the returned device, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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