It was reported that the patient underwent a procedure, performed to treat a target lesion in the minimally stenosed and tortuous left superficial femoral artery, occluded mostly with clot.The 2.5 x 120 mm armada 14 dilatation catheter was inflated twice, to 10 atmospheres, without issue.During deflation, the balloon partially deflated.No additional intervention was performed to fully deflate the armada balloon.The device was pulled back into the sheath and then deflated.There was no adverse patient effect or clinically significant delay.No additional information was provided.
|
The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
|