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 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 lesion in the distal right coronary artery.A non-abbott balloon was used for pre-dilatation.A 3x12mm nc traveler balloon dilatation catheter (bdc) faced resistance with the anatomy during advancement, and the balloon ruptured during the first inflation at nominal pressure.The device was removed without resistance, and a 3x12mm non-abbott device 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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