The hydromark breast biopsy site marker is used to mark tissue 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 confirmed that the spring at the distal end of the plunger rod remained in the patient breast.A patient update is not available at this time.Three (3) attempts were made to gain additional information on the patient.On third attempt, we were notified that the treating physician was out of the office and unable to get further patient information at this time.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 cause the reported event.Due to the potential for a subsequent procedure or other treatment intervention and pursuant to 21 cfr 803, we are submitting this medwatch report.
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The sales rep reported that during a stereo bx procedure, post sampling a hydromark applicator was inserted into the bx needle to mark site.During deployment of the tissue marker, it appears part of all of the deployment spring came out with the marker (based on post clip images).
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