VersaCross Connect LAAC Access Solution

Description of Event or Problem

IT WAS REPORTED THAT THE RADIOFREQUENCY (RF) WIRE COULD NOT CROSS THE SEPTUM. DURING A LEFT ATRIAL APPENDAGE CLOSURE (LAAC) PROCEDURE A VERSACROSS CONNECT LAAC ACCESS SOLUTION RF WIRE WAS USED. THE VERSACROSS CONNECT DILATOR INSIDE THE WATCHMAN TRUSTEER SHEATH WAS ADVANCED TO THE SUPERIOR VENA CAVA (SVC) OVER THE RF WIRE, THEN THE SHEATH AND DILATOR WERE DROPPED ONTO THE SEPTUM AFTER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING ENSURED PROPER PLACEMENT TO CROSS THE SEPTUM THE RF WIRE WAS ADVANCED OUTSIDE THE DILATOR 1-2MM. THE BUTTON ON THE GENERATOR TO DELIVER RF ENERGY WAS ACTIVATED, BUT THE WIRE DID NOT CROSS THE SEPTUM. NO ERROR MESSAGE APPEARED. ALL CONNECTIONS WERE CHECKED AND ANOTHER ATTEMPT TO CROSS THE SEPTUM WAS MADE, BUT THE WIRE STILL DID NOT ADVANCE. IT WAS DECIDED TO REPLACE THE RF WIRE, AND TO USE A VERSACROSS FIXED CURVE SHEATH WITH THE RF WIRE. AFTER POSITIONING THE SHEATH AND VERIFYING A PROPER CROSSING POINT WITH TEE AGAIN, THE GENERATOR BUTTON WAS ACTIVATED, AND THE REPLACEMENT WIRE WAS ABLE TO CROSS THE SEPTUM. THE LAAC PROCEDURE WAS THEN CONTINUED AND COMPLETED WITH NO PATIENT COMPLICATIONS.

Additional Manufacturer Narrative

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, OR IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.