The device was not returned for evaluation.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 similar incidents and/or complaints from this lot.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The nc traveler device is currently not commercially available in the us; however, it is similar to a device sold in the us.
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It was reported that the procedure was performed to treat a lesion in the heavily calcified, non-tortuous proximal right coronary artery.A 3.5x12mm nc traveler balloon dilatation catheter (bdc) experienced resistance with the anatomy during advancement, and the balloon ruptured during the first attempt to inflate at 14 atmospheres.The bdc was removed without resistance, and an unspecified balloon was used 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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