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

Catalog Number	STAR0831
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	06/01/2018
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.One mammostar marker, product code (b)(4) was placed at the time of initial biopsy.At some point after the marker placement, the patient developed a reaction around the area of the marker.An identical reaction to the one described above was also reported in a second patient at the same facility on the same day.In this case, one mammostar marker, product code (b)(4) was placed at the time of initial biopsy.See mdr report #: 2134494-2018-00002 for additional information.In both cases, the marker is no longer in place.One patient had the marker surgically removed and the other patient had the marker expel on its own.No testing on the specific device has been conducted as the device was not returned for evaluation.The specific device history record was not reviewed because lot identification information could not be obtained.Biocompatibility testing was conducted as part of the initial qualification of this device and was determined to be non-immunogenic.In addition, appropriate controls are in place for every lot manufactured to ensure that no discrepancies exist before release including packaging and sterilization records.A related experience review was conducted and 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.
Event or Problem Description
It was reported that after deployment the marker moved superficial under the skin.This, in the customer opinion, caused an infection.

• 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: 7685479
• Report Number: 2134494-2018-00001
• Device Sequence Number: 16493332
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2018

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 Catalogue Number: STAR0831
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/13/2018
• 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: BIOPSY NEEDLE; OTHER ACCESSORIES
• Outcome Attributed to Adverse Event: Other