PRESSUREWIRE¿

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THE PRESSUREWIRE X, WIRELESS DEVICE WAS INTENDED TO BE USED IN A RIGHT CORONARY ARTERY WITH SEVERE TORTUOSITY. AFTER THE DEVICE WAS INADVERTENTLY ADVANCED INTO A SIDE BRANCH. DUE TO APPARENT ATHEROSCLEROTIC CHANGES AT THE OSTIUM OF THE SIDE BRANCH, THE WIRE BECAME STUCK AT THE SIDE BRANCH ENTRY, MAKING REMOVAL DIFFICULT. A MICROCATHETER WAS SUBSEQUENTLY USED, THE PRESSUREWIRE WAS SUCCESSFULLY RETRIEVED; HOWEVER, THE TIP WAS DAMAGED AND THE COIL SEGMENT WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRESSUREWIRE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.