The flash mini device used in the procedure was returned to ostial corporation for evaluation.A three (3) page summary of the evaluation has been attached.No issues were found with the performance of the returned device, though it was evident that the user had attempted to withdraw the inflated device into the guide catheter, resulting in the reported break in the catheter shaft.The inflation lumens on either side of the break were inspected and it was found that the proximal lumen was clogged by crystalized contrast and notably thicker contrast than expected (based on comparison to fresh contrast of the same nominal viscosity as the contrast used during the procedure).Following removal of the thick/crystalized contrast from the proximal lumen, there were no issues noted injecting or removing fresh contrast from the proximal balloon inflation lumen.While the thick/crystalized contrast is suspected to be the root cause of the reported problem, no definitive conclusions can be drawn as thickening/crystallization could have occurred following the procedure and issues with other accessory devices (e.G.Broken deflation syringe/indeflator) could also have led to this type of problem.In addition to the case details and device evaluation, ostial corporation reviewed the manufacturing documentation associated with the device lot used during the procedure.No issues were noted that would have contributed to the reported incident and all tensile strengths were found to be appropriate/well above the amount of force that is typically applied to the catheter.The instructions for use (ifu) for the product were also reviewed and it was verified that the ifu contains both appropriate instructions for using a 50/50 mixture of contrast/saline solution for inflation of the balloons and precautions/instructions for removing the device if excessive resistance is encountered when attempting to withdraw flash into the guide catheter.
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