The device was not returned to numed for evaluation.Through additional communications with the facility it was learned that the device was being used off-label for an unapproved use.It was also stated that the catheter inflated and deflated without issue.From the wording used in the report, it sounds like the catheter was not fully deflated before being pulled back into the introducer which caused the balloon to catch and tear apart.The instructions for use this catheter is approved for valvuloplasty of the pulmonary and aortic valves.This was being used off-label for a re-dilation of a stent in the ivc.The instructions for use has the following warning: "the catheter is not intended for use with stents." the instructions for use also include the following precautions: -if resistance is felt upon removal, then the balloon, guidewire, and the sheath should be removed together as a unit, particularly if balloon rupture or leakage is known or suspected.This may be accomplished by firmly grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting motion combined with traction.- before removing the catheter from the sheath it is very important that the balloon is completely deflated.A comparative catheter was pulled and tested for rated burst pressure as well as bond strength.It was the same catalog number as the complaint catheter.The catheter met all specifications for both the labeled rated burst pressure as well as bond strength.
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