MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number	STAR1101
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Mammostar biopsy markers are migrating within the breast tissue of patients following their placement with a breast tissue biopsy.As a result, patients present in follow-up with their original biopsy site markers improperly placed.Manufacturer sent a new model.

• Brand Name: MAMMOSTAR
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond road; saint paul MN 55110
• MDR Report Key: 16239991
• Report Number: 16239991
• Device Sequence Number: 12400334
• Product Code: NEU
• UDI-Device Identifier: 00858015005394
• UDI-Public: 00858015005394
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/10/2023
• Report Date (Section F): 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: STAR1101
• Device Catalogue Number: STAR1101
• Device Lot Number: 2204116A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/10/2023