The device was returned for analysis.The reported material rupture was able to be confirmed.Additionally, scratches on the balloon and peeling balloon material were noted.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.It should be noted that the nc trek rx coronary dilatation catheter instructions for use (ifu), states: caution: all air must be removed from the balloon and displaced with contrast prior to inserting into the body otherwise, complications may occur.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the mildly calcified anatomy resulted in the noted scratched and peeling balloon material; thus compromising the balloon material and ultimately resulting in the reported material rupture.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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