SENOMARK ULTRA BREAST TISSUE MARKER

Description of Event or Problem

ON (B)(6) 2026, A PATIENT UNDERWENT A MARKER PLACEMENT PROCEDURE USING THE SENOMARK INSTRUMENT. DURING THE PROCEDURE, THE PHYSICIAN AND TECHNOLOGISTS, THEY SWITCHED TO MARKER MODE ON THE ENCOMPASS AND SELECTED THE 12 O CLOCK POSITION. THEY THEN ALIGNED THE YELLOW ARROW OF THE MARKER WITH THE BUTTON SIDE OF THE DRIVER (1200) AND ATTEMPTED TO DEPLOY THE MARKER BUT ENCOUNTERED RESISTANCE. AN IMAGE WAS TAKEN TO CHECK DEPLOYMENT, BUT NO MARKER WAS VISIBLE WITHIN THE BREAST. THEY ATTEMPTED TO REMOVE THE MARKER AND, PER THE RADIOLOGIST, HAD TO YANK IT OUT OF THE BREAST/NEEDLE AS IT WAS STUCK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F: THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.