It was reported that the procedure was to treat a lesion located in the circumflex artery that was non calcified and non tortuous.During advancement of the trek rx 3.00 x 12mm bdc balloon over the guide wire, markers were not observed under x-ray.Therefore, the balloon catheter was removed, and no markers were physically present.It was decided to perform direct stenting to complete the procedure.There were no reported 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 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 was unable to determine a conclusive cause for the reported complaint.However, factors that may cause the balloon marker to be missing and/or not visible under fluoroscopy include, but not limited to, manufacturing, location of anatomy and/or anatomical conditions, the type of contrast solution, contrast mixing ratio, patient anatomy, patient disease state and fluoroscopy equipment.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.D9, h3.The device is not available for evaluation.
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