On (b)(6) 2020, a gore® viabahn® vbx balloon expandable endoprosthesis(vbx) was being placed as a innominate stent in conjunction with transcarotid artery re-vascularization (tcar) procedure.During the advancement of the device the physician had to use excessive force to get the device into place.After the device was successfully deployed, the physician was removing the device catheter through the 8fr tcar introducer sheath, and felt resistance.After the resistance was felt he continued to withdraw the catheter, and the catheter broke.The physician removed the remainder of the catheter and sheath in tandem.When it was removed, it was suspected that the balloon portion of the catheter hung up on the sheath tip.Patient did not suffer any adverse effects.
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