VERSACROSS LARGE ACCESS SOLUTION

Additional Manufacturer Narrative

IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING A RF WIRE AND VERSACROSS ACCESS SOLUTION DEVICE WAS SELECTED FOR USE. DURING VENOUS ACCESS FOR A PLANNED WATCHMAN FLX IMPLANT, THE PHYSICIAN ATTEMPTED TO ADVANCE A VERSACROSS CONNECT WIRE INTO THE SUPERIOR VENA CAVA (SVC) BUT WAS UNABLE TO ACCESS THE SVC, AND THE WIRE INSTEAD ADVANCED INTO THE INFERIOR VENA CAVA. TEE IMAGING WAS IN USE, AND NO PERICARDIAL EFFUSION WAS PRESENT PRIOR TO VENOUS ACCESS. WITHIN THE FIRST FEW MINUTES OF ATTEMPTING TO POSITION THE VERSACROSS WIRE, A NEW PERICARDIAL EFFUSION WAS IDENTIFIED ON TEE. THE EFFUSION WAS POSTERIOR AND LOCATED AROUND THE RIGHT ATRIUM. THE PATIENT DEVELOPED CARDIAC TAMPONADE WITH HEMODYNAMIC INSTABILITY, INCLUDING BLOOD PRESSURE DROP, PEA ON EKG, AND THE NEED FOR CHEST COMPRESSIONS. A PERICARDIOCENTESIS WAS PERFORMED, BUT THE EFFUSION CONTINUED TO ACCUMULATE. THE CASE WAS ABORTED PRIOR TO TRANSSEPTAL PUNCTURE, AND NO WATCHMAN DEVICE WAS IMPLANTED. THE PATIENT WAS EMERGENTLY TAKEN FOR STERNOTOMY. UPON OPENING THE CHEST, THE SURGICAL TEAM IDENTIFIED THAT THE RIGHT VENTRICULAR PACER LEAD HAD PERFORATED THROUGH THE RIGHT VENTRICLE, CAUSING THE EFFUSION AND TAMPONADE. THE PATIENT RECEIVED 21 UNITS OF BLOOD DURING RESUSCITATION AND SURGICAL REPAIR. THE AMOUNT AND COLOR OF PERICARDIAL FLUID REMOVED PRIOR TO OPEN-HEART SURGERY WERE NOT RECORDED. THE PERFORATION WAS REPAIRED SURGICALLY, AND THE PATIENT WAS STABILIZED. A DRAIN WAS LEFT IN PLACE. THE PATIENT WAS TRANSFERRED TO THE ICU, AWAKE BUT STILL INTUBATED SEVERAL HOURS LATER. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY. THE PATIENT WAS TAKING ELIQUIS 5 MG BID AT THE TIME OF THE EVENT. PATIENT HAS BEEN DISCHARGED.