The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 week, and be permanently visible by x-ray and mri.The device has not been returned for evaluation, which prevents a full investigation and analysis of a root cause at this time.However, this failure mode has been identified in the risk management file for the effects of potential foreign body reaction with a potential for injury to the patient and/or user.Follow up medical intervention may be necessary.Although it could not be concluded that our device caused or contributed to this event, through evaluation by our medical advisor on similar events, this has been determined to be reportable pursuant to 21 cfr 803.
|
Devicor medical products, inc.Received a report from the distributor stating, "marker clip was inserted in (b)(6) 2018.Patient follow up in (b)(6) 2019 showed a new nodule around the clip.Surgical excision of the nodule shows this is a foreign body granuloma, suspected to be a reaction to the gel marker clip".This has been documented in our system as record # (b)(4).
|