VersaCross Connect LAAC 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING A FLX PRO PROCEDURE TO TREAT LEFT ATRIAL APPENDAGE OCCLUSION (LAAO), THE VERSACROSS WIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE WAS INSERTED INTO A NON-BOSTON SCIENTIFIC NEEDLE. UPON REMOVAL, THE INSULATION WAS NOTED TO BE MISSING AND WAS NOT VISUALIZED OUTSIDE OF THE PATIENT'S BODY. THE PHYSICIAN PROCEEDED WITH IMPLANTATION OF THE WATCHMAN DEVICE. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT WIRE FOR THE TRANSSEPTAL PUNCTURE. INTERVENTIONAL RADIOLOGY WAS CALLED TO ATTEMPT LOCALIZATION AND TO SNARE THE MISSING INSULATION. THE PLANNED NEXT COURSE OF ACTION INCLUDED SNARING OR OPEN SURGERY. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. THE PATIENT OUTCOME WAS REPORTED AS FULLY RECOVERED. THE DEVICE WILL NOT BE RETURNED AS IT WAS RETAINED BY THE CUSTOMER.