The hydromark breast biopsy site marker is used to mark the biopsy site during a percutaneous breast biopsy procedure, visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and mri.The 4010-03-09-t3 hydromark breast biopsy site marker is designed for use with the atec 9 gauge biopsy systems and encore 10 ga directional vacuum-assisted biopsy devices.The device is not available to be returned to the manufacturer for evaluation.However, based on post deployment images, it is possible that the spring at the distal end of the plunger rod remained in the patient breast.Follow up with the customer indicated that the patient is considering a mastectomy, but has yet to decide on a surgical procedure.However, once the patient has decided on a surgical procedure, customer will retain object to return to manufacturer for further analysis.In the information for use it states that when removing the hydromark from the breast, the following steps should be followed.Rotate the hydromark delivery system and the probe 180 degrees to position the delivery system and probe's apertures away from the deployed hydromark marker.Slowly remove the hydromark delivery system and probe as one unit from the breast.Failure to adhere to either of these steps could potentially cause the reported event.Customer has declined further retraining on proper procedure for marker deployment.Due to the potential for a subsequent procedure or other interventional treatment and pursuant to 21 cfr 803, we are submitting this medwatch report.
|