The mammostar biopsy site identifier is a sterile, single-patient use device that is placed into soft tissue during a biopsy procedure to radiographically mark a surgical location.In all cases, the mammostar biopsy site identifier is used in conjunction with a biopsy needle and other accessories to complete the biopsy procedure.It was reported that the patient had one mammostar biopsy site identifier (b)(4) place after a biopsy procedure on (b)(6) 2020.The procedure was completed without incident at the time.On (b)(6) 2020, the patient reported that the incision site had reopened and the marker expelled on its own.No testing on the specific device has been conducted as the device was not returned for evaluation.The device history record was reviewed and noted no discrepancies existed before release including but not limited to packaging and sterilization records.Biocompatibility testing was conducted as part of the initial qualification of this device and was determined to be non-immunogenic.A related experience review was conducted and identified one nearly identical reaction to the one described here within on a patient in 2018 at the same facility and with the same physician in italy.No other instances of this event have been reported for this catalog number at any other facility.Although it could not be concluded that our device caused or contributed to this event, it has been determined to be reportable pursuant to 21 cfr 803 due to the reported adverse event.As such, we are submitting this medwatch report.The information contained herein is being provided to fda to comply with regulations relating to medical device reporting and is based on information submitted by others that may not be factually correct.This submission does not constitute a determination or admission that a device has malfunctioned or that a device is related to a death or injury.
|