Device evaluated by mfr.: returned product consisted of an emerge otw balloon catheter.The device was visually and microscopically examined.At 96.8cm, and 98.4cm from the strain relief of the device, the shaft was kinked.At 4mm from the tip of the device, for a length of 12mm, the guidewire lumen and distal markerband were flattened.The folds of the balloon were tight however, they were manipulated open but have no signs of inflation.
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Reportable based on device analysis completed on 04-apr-2022.It was reported that shaft kink occurred.The 95% stenosed, 10x2.00mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.00mm x 12mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the delivery shaft was kinked.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed markerband damage.Returned product consisted of an emerge otw balloon catheter.The device was visually and microscopically examined.At 96.8cm, and 98.4cm from the strain relief of the device, the shaft was kinked.At 4mm from the tip of the device, for a length of 12mm, the guidewire lumen and distal markerband were flattened.The folds of the balloon were tight however, they were manipulated open but have no signs of inflation.Product analysis confirmed the reported event, as the shaft of the device was kinked.
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