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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The nc traveler is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.
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It was reported that the procedure was performed to treat a moderately tortuous and heavily calcified in-stent restenosis in the distal right coronary artery.A 2.5x15mm nc traveler rx balloon dilatation catheter (bdc) was advanced; however, resistance with the stent was felt.Once at the target lesion, the pressure could not be increased to greater than nominal (12 atmosphere).The contrast was observed leaking out of the balloon under cine and the pressure spontaneously decreased; therefore, it was judged as balloon rupture.The procedure was successfully completed with a non-abbott balloon catheter.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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