MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 8GA; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	STAR0831
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that approximately 6 weeks after deployment of the mammostar marker, the patient reported that the incision site had been reopened and the marker came out.

• Brand Name: MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 8GA
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond road; saint paul MN 55110 5876
• MDR Report Key: 10871794
• Report Number: 2134494-2020-00001
• Device Sequence Number: 11422043
• Product Code: NEU
• UDI-Device Identifier: 00858015005325
• UDI-Public: 00858015005325
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K100994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2022
• Device Model Number: STAR0831
• Device Catalogue Number: STAR0831
• Device Lot Number: 1708208A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR