E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by mfr: the device was returned for evaluation.Visual, tactile, microscopic and device-to-device interaction analysis was performed on the device.A visual examination of the balloon identified no damages.Balloon folds were tightly folded.No issues were noted along the hypotube shaft.A cut was noted on the outer polymer extrusion, 5mm cut from port exchange.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device could be loaded and tracked on a 0.0140" test guidewire and a 5f guide catheter with no issues.No other issues were identified during the product analysis.
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Reportable based on device analysis completed on (b)(6) 2023.It was reported that there was resistance to advance through the guide catheter.The 38 mm x 2.5 mm, 75% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery (lad).A 10mm x 2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that after the tip was connected to the guide wire, there was resistance in the internal delivery of the guide catheter, and it was difficult to smoothly advance through the guide catheter.There a significant bend involved in the target lesion.The procedure was completed with another of the same device.There were no patient complications reported, and patient was stable post procedure.However, device analysis revealed that there was a cut was noted on the outer polymer extrusion, 5mm cut from port exchange.
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