The device was returned for analysis.The reported material rupture was confirmed.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 similar incidents from this lot.The investigation determined the reported balloon rupture appears to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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It was reported that the procedure was to treat the left common femoral artery (cfa) with severe calcification and no tortuosity.The 7.0x40mm armada 35 balloon catheter had no resistance during advancement and was inflated once with a pressure of 6 atmospheres (atms), however, upon pulling negative pressure, blood was noticed coming back from the balloon.The device was soaked prior to use.The device was prepared (air aspiration) outside the anatomy prior to use.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
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