Image review: two photographic images of cine images of the balloon catheter inflated within the targeted vessel anatomy were received.Both images show a section of the balloon not fully inflated at a focalized point, (e.G.Candy wrapped).The balloon is being used to post-dilate a stent.The first image the balloon catheter is being used to post-dilate the proximal end of the stent.The second image the balloon catheter is being used to post-dilate the distal end of the stent.The focalized balloon twist (e.G.¿candy wrapper¿ is located approximately in the same position in both inflations).Product analysis: the pacific xtreme pta balloon catheter was received by medtronic for evaluation, loosely coiled within its opened labelled pouch.No ancillary devices were received for analysis.The pacific xtreme catheter was received with the balloon in post-inflation profile, (e.G.Not tightly wrapped or winged).The inner guidewire lumen exhibited undulation of being stretched.The balloon chamber exhibited twisting witness marks.A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed; a steady stream of fluid was observed exiting the distal end of the catheter.A 0.018¿ guidewire was loaded through the distal tip and navigated out the proximal hub with ease.The lot number information printed on the y-manifold is consistent with the pouch label and reported event.A 10cc water filled syringe was attached to the inflation lumen luer lock.A vacuum was able to be pulled and maintained; indicating no leaks in the inflation pathway or balloon chamber.The syringe was lightly pressurized, and the twisting witness marks were still visible in the balloon chamber material.A 20cc water filled syringe with manometer was attached to the inflation lumen luer lock and pressurized to nominal pressure of 6 atm; no leaks noted but twisting witness marks are still present in the balloon chamber material.The 20cc syringe with manometer was pressurized to rated burst pressure, (14 atm); no leaks noted but twisting witness marks are still present in the balloon chamber material.The balloon catheter was fully deflated, and the guidewire was removed; twisting witness marks remained in the balloon chamber material.If information is provided in the future, a supplemental report will be issued.
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