Device evaluated 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 balloon.The balloon was loosely folded.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There were pinholes on the shaft 13mm and 14mm distal from the exit notch.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 29-oct-2020.It was reported that balloon inflation failure occurred.The severely stenosed target lesion was located in the left circumflex artery.A 1.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, during inflation, the balloon failed to inflate despite application of pressure.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed a shaft hole.
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