(b)(6).Device evaluation by mfr: returned product consisted of a maverick 2 balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There were numerous kinks.There was contrast and blood in the inflation lumen, and blood in the guidewire lumen.The balloon was loosely folded.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a longitudinal tear 3mm long starting at the distal marker band and extending distally.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there would have been difficulty inflating the balloon.
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Reportable based on device analysis completed on 26aug2020.It was reported that balloon leak and inflation failure occurred.The target lesion was located in a coronary artery.A 2.50mm x 20mm maverick 2 balloon catheter was advanced for use; however, it was noted that the balloon was leaking gas and could not pre-dilate.The procedure was completed with another of the same device.No patient complications were reported and the patient status was stable.However, device analysis revealed a balloon longitudinal torn.
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