It was reported that the procedure was to treat a lesion in the left iliac vein.
A 14x40mm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion without issue.
Upon the first inflation to nominal pressure, the balloon ruptured.
Resistance was noted during removal of the bdc from the anatomy.
Upon removal, it was noted that a piece of balloon material separated and remained in the vessel.
A non-abbott stent was advanced without issue and implanted to cover the piece of separated balloon.
A non-abbott bdc was used to successfully complete the procedure.
There was no adverse patient effect and no clinically significant delay in the procedure.
No additional information was provided.
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