MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES MAMMOSTAR TISSUE MARKER

Catalog Number	STAR1401
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A retrospective chart review post market clinical follow-up study reported that an immune response was observed with a causal association.Clinical management included topical medication resulting in a full recovery.The procedure was carried out despite the presence of an infection, which is a known risk factor.Despite a warning in the ifu, the marker was inserted into a blood vessel.
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.No testing on the specific device has been conducted as the device was not returned for evaluation.A review of the device history record for this specific lot could not be performed because there was no lot number available associated with this complaint.Upon release, every lot is reviewed and certified to have met all specification requirements.Biocompatibility testing was conducted as part of the initial qualification of this device and was determined to be nonimmunogenic.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.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.

• Brand Name: MAMMOSTAR TISSUE MARKER
• Common Device Name: TISSUE MARKER
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES; 1290 hammond rd; st. paul MN 55110
• Manufacturer (Section G): 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: 19399287
• Report Number: 2134494-2024-00015
• Device Sequence Number: 20889863
• Product Code: NEU
• UDI-Device Identifier: 00858015005424
• UDI-Public: 00858015005424
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2024

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: STAR1401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Female