It was reported that the procedure was performed to treat a heavily calcified, moderately tortuous common carotid artery that was 90% stenosed.After crossing the lesion with an unspecified wire and an unspecified embolic protection device, a 5x20mm viatrac plus balloon dilatation catheter (bdc) was positioned.The balloon was pressurized to nominal pressure, but the balloon did not open to full diameter as a leak was observed from the hub.The bdc was removed and replaced with a new 5x20mm viatrac balloon to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.Based on the information provided, a definitive cause for the reported inflation issue and leak could not be determined.It may be possible that the inflation device was not properly connected to the hub, or damage to the hub occurred resulting in the reported inflation problem and leak at the hub; however, without having the device to examine, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.D9, h3: corrected to not returning.
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