Device evaluated by mfr.: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in the guidewire lumen 21cm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
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Reportable based on device analysis completed on 11-feb-2021.It was reported that balloon damage occurred.The chronic totally occluded target lesion was located in the moderately calcified superficial femoral artery.A 6.0x220x150-hybrid sterling balloon catheter was advanced for dilation.However, on initial inflation under fluoroscopy, the balloon was twisting approximately 5cm from the proximal marker.The device was removed and the procedure was completed with another of the same device.No patient complications nor harm were reported.However, returned device analysis revealed shaft hole.
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