We have received the complaint device for evaluation and we have confirmed the reported incident.The proximal ligature was observed to have partially unwound.The balloon was observed to have partially inflated beyond the inflation holes.As a result, the user could not deflate the balloon.The distal ligature was properly binding onto the shaft of the catheter.No necking or kinking of the extrusion was observed.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Further, we have not received any other complaints of a similar nature for devices from this lot.As part of our manufacturing process, a 100% visual balloon and winding inspection are performed on the manufactured product.However, it is possible that the tension or the glue applied underneath the balloon during the balloon tying process was inadequate resulting in the slippage of the ligature from its position.It is also possible that some anatomical or procedural factors may have contributed to the ligature failure while removing the adherent material from the patient's narrowed blood vessel.As stated in our ifu, the arterial embolectomy catheter is not recommended for the removal of fibrous, adherent or calcified material ( eg.Chronic clot, atherosclerotic plaque ).This catheter is not designed to withstand the additional pull force needed to remove these materials.There was no injury to the patient as the result of this incident.Another lemaitre over-the-wire embolectomy catheter was used to complete the procedure.
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