The returned product was subjected to a technical analysis and the corresponding product release documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for this event.The technical investigation of the complaint instrument confirmed that the balloon has not been inflated and was returned in a slightly unfolded state.After introduction of a 0.018 inch reference guidewire, functional testing was performed by successfully inflating the balloon with up to 15 atm (rbp).Microscopic inspection of the balloon surface revealed no damage, irregularity, or leakage.Review of the product release documentation confirmed that the instrument was manufactured according to specifications and passed all in-process and final inspections.In addition to visual inspections each instrument is tested for air tightness by means of a pressure test and a helium leakage test.We can therefore confirm that the instrument was delivered in a leak-proof condition.Based on the conducted investigations of the device being subject to this complaint, we can confirm that no product failure could be determined.
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