MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 10GA; MARKER, RADIOGRAPGIC, IMPLANTABLE

Model Number	STAR1032
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Codes	Abscess (1690); Foreign Body Reaction (1868)
Date of Event	10/12/2020
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 (star1032) place after a biopsy procedure approximately 2 years ago.The procedure was completed without incident at the time.On (b)(6) 2020, the patient came to hospital because she has the a warm red area on her breast under the nipple.It was red with a white center spot.The doctor decided to try to remove the spot.A lot of white/yellow liquid came out.The physician discovers a "gel" with ceramic inside, looking like a mammostar.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 with no other instances of this event having been reported for this catalog number at any other facility.Although it could not be concluded that this 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.
Event or Problem Description
It was reported that the patient had one mammostar biopsy site identifier (star1032) place after a biopsy procedure approximately 2 years ago.In (b)(6) 2020, the patient came to hospital because there was a warm and red spot on her breast near the nipple.The physician decided to remove the spot.A lot of white/yellow liquid came out.The physician discovers a "gel" with ceramic inside, looking like a mammostar.The st vab 2 yrs ago was uneventful, the scar is not at the same area of where the marker came out.

• Brand Name: MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 10GA
• Common Device Name: MARKER, RADIOGRAPGIC, IMPLANTABLE
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond road; saint paul MN 55110
• MDR Report Key: 11347044
• Report Number: 2134494-2021-00001
• Device Sequence Number: 4107845
• Product Code: NEU
• UDI-Device Identifier: 00858015005370
• UDI-Public: 00858015005370
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

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: 11/06/2021
• Device Model Number: STAR1032
• Device Catalogue Number: STAR1032
• Device Lot Number: 1609170A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REVOLVE BIOPSY SYSTEMOTHER ACCESSORIES
• Outcome Attributed to Adverse Event: Other