The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no indication of a lot specific product quality issue.Based on the information provided, the reported resistance during advancement and balloon rupture appear to be due to circumstances of the procedure.It is likely that the resistance and balloon rupture occurred due to interaction with the lesion calcification causing damage to the outer surface of the balloon resulting in rupture during inflation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
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It was reported that the procedure was performed to treat a mildly calcified, mildly tortuous superficial femoral artery.The 6.0x200mm armada 18 balloon dilatation catheter was positioned with resistance during advancement due to the anatomy.During inflation, the balloon ruptured at 10atm on the first inflation.The balloon catheter was removed without issue and replaced with a new armada 18 to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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