TEMPO AQUA

Additional Manufacturer Narrative

THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem

AS REPORTED, THERE WAS DIFFICULTY ADVANCING A 5F 100CM SIDEWINDER SIMMONS II (SIM2) TEMPO AQUA DIAGNOSTIC CATHETER TOWARD THE LESION AND THE DEVICE FRACTURED IN THE AORTIC ARCH. THE FRACTURE CAUSED THE DEVICE TO SEPARATE INTO MULTIPLE PIECES, AND THE SEPARATED CATHETER SEGMENT WAS REMOVED THROUGH EMERGENCY MINIMALLY INVASIVE INTERVENTION. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO ATTEMPT TO SHAPE IT DURING PREPARATION. THE FACILITY DID NOT USE ULTRAVIOLET (UV) LIGHT OR OZONE FOR ROOM STERILIZATION. THE INTENDED PROCEDURE WAS CAROTID ARTERY STENTING (CAS) VIA FEMORAL ARTERY ACCESS. WITHIN THE AORTIC ARCH, THERE WAS NO CALCIFICATION, TORTUOSITY, STENOSIS, OR ACUTE ANGLE. THE DEVICE WAS IN AN ACUTE BEND DURING THE PROCEDURE, WITH NO INDICATION OF CATHETER KINKING PRIOR TO FRACTURE. THE DEVICE WILL BE RETURNED FOR EVALUATION.