Description of Event or Problem · 1
ON 26-MAR-2021 HEALTH BEACONS BECAME AWARE OF AN INCIDENT AT LIFEBRIDGEHEALTH BREAST CENTER, IN (B)(6). THE DOCTOR WAS PLACING A LOCALIZER TAG UNDER STEREO GUIDANCE INTO A PATIENT AND THE LOCALIZER TAG CRACKED IN HALF. THE TAG WAS PLACED NEXT TO A CLIP, IN PERFECT POSITION. THE DOCTOR CONFIRMED THAT THE PATIENT'S BREAST TISSUE WAS VERY DENSE AND HARD DUE TO SCAR TISSUE. THE TAG COULD NOT BE DETECTED BY A READER, AS IT WAS NOT TRANSMITTING. THE PATIENT WAS TAKEN TO ULTRASOUND, WHERE THE CLIP AND TAG WERE SEEN. THE HEALTH BEACONS INVESTIGATOR COMMUNICATED WITH HOLOGIC REPRESENTATIVES TO GATHER MORE INFORMATION FROM ACCOUNT REPRESENTATIVE ABOUT THIS INCIDENT. IMAGES WERE PROVIDED, WHICH SHOW BROKEN TAG (ATTACHED TO THIS REPORT). IT WAS CONFIRMED THAT ON (B)(6) 2021, THE TAG WAS REMOVED, TOGETHER WITH TARGET TISSUE, DURING THE REGULARLY SCHEDULED SURGERY. IT WAS CONFIRMED THAT ALL FRAGMENTS WERE CONTAINED IN THE SPECIMEN AND REMOVED FROM THE PATIENT, WITHOUT ADDITIONAL SURGICAL INTERVENTION. THE REMOVED TISSUE WAS IDENTIFIED AS CANCEROUS, WHICH MOST LIKELY CONTRIBUTED TO THE HIGH DENSITY OF THE TISSUE. IT IS NOTED BY HEALTH BEACONS THAT IN THIS INSTANCE OF TAG BREAKAGE, THE NEEDLE WAS BEING PUSHED AGAINST RESISTANCE, CONTRARY TO THE INSTRUCTIONS FOR USE GUIDANCE.