Physician attempted to use an inpact admiral drug coated balloon with a non-medtronic 6fr sheath during a procedure to treat a lesion in the patient¿s mid superficial femoral artery (sfa).An inflation device was used for balloon inflation.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped without issue.The device was not passed through a previously deployed stent.No resistance was encountered during advancement.It is reported the inapct admiral was incompatible with the 6fr sheath.The physical had to pull the entire sheath with the balloon inside out.A second sheath was then placed, and the procedure completed.No patient injury reported.
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