Age at time of event: 18 years or older.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 in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.The device was soaked in a water bath for two hours to loosen the blood and contrast in the device.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.There was a pinhole at the distal marker band.There was no marker band damage detected.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 19feb2021.It was reported that inflation issue occurred.Vascular access was obtained via femoral artery.The stenosed target lesion was located in the left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation; however, the balloon was not inflating correctly.The device was removed and the procedure was completed with another of the same device.No patient complications were reported and the patient was stable.However, device analysis revealed balloon pinhole.
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