MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES BIOMARC TISSUE MARKER DEVICE

Model Number	040230
Medical Device Problem Codes	Mechanical Problem (1384); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Biomarc tissue markers are sterile, single patient use, pyrolytic carbon coated zirconium oxide discrete markers that are visible on standard radiographs (x-ray, mammography, fluoroscopy, kv, and ct) as well as ultrasound, and magnetic resonance imaging (mri).Biomarc tissue markers are placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.Biomarc tissue markers are supplied pre-loaded in a sterile, pyrogen free, single patient use deployment device.It was reported that the surgeon found a piece of the marker applicator sheath inside the breast during an excision.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 malfunction.As such, we are submitting this medwatch report.The information contained herein is being provided to the 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 constittute a determination or admission that a device has malfunctioned or that a device is related to death, injury or malfunction.
Event or Problem Description
The surgeon reported finding a piece of the marker applicator sheath inside the breast during an excision.

• Brand Name: BIOMARC TISSUE MARKER DEVICE
• Common Device Name: BIOMARC
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES; 1290 hammond rd.; st. paul MN 55110
• Manufacturer Contact: tina wittchow ; 1290 hammond rd; st. paul, MN 55110 ; 6516538512
• MDR Report Key: 21172509
• Report Number: 2134494-2024-00022
• Device Sequence Number: 11831178
• Product Code: NEU
• UDI-Device Identifier: 00858015005226
• UDI-Public: 00858015005226
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K100994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2025

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: 040230
• Device Lot Number: 2210316B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female