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 DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECTS TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE NC TRAVELER DEVICE IS NOT CURRENTLY COMMERCIALLY AVAILABLE IN THE U.S.; HOWEVER, IT IS SIMILAR TO A DEVICE SOLD IN THE U.S.
D
Patient 1
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED MID RIGHT CORONARY ARTERY (MRCA). DURING ADVANCEMENT OF A 3.0X08MM NC TRAVELER IT MET RESISTANCE WITH THE ANATOMY. ONCE AT THE LESION THE BALLOON WAS INFLATED ONCE AT 8 ATMOSPHERES WHEN ANGIOGRAPH INDICATED CONTRAST LEAKAGE. THE BALLOON WAS REMOVED, AND A RUPTURE WAS NOTED AT THE MIDDLE SECTION OF THE BALLOON. ANOTHER UNSPECIFIED BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.