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

Model Number	STAR0832
Medical Device Problem Codes	Entrapment of Device (1212); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During clip deployment into breast post biopsy, tip of micromarker device became lodged into tissue.Tip had to be manually removed.Post mammogram showed no clip migration or hematoma.
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 during clip deployment into breast post biopsy, tip of micromarker device became lodged into tissue.Tip had to be manually removed.Post mammogram showed no clip migration or hematoma.The device history record was reviewed and noted no discrepancies existed before release including but not limited to device length and tip conformity to the specification.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 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
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): CARBON MEDICAL TECHNOLOGIES, INC; 1290 hammond road; st. paul MN 55110
• Manufacturer (Section G): CARBON MEDICAL TECHNOLOGIES, INC.; 1290 hammond road; saint paul MN 55110
• Manufacturer Contact: tina wittchow ; 1290 hammond road; saint paul, MN 55110 ; 6516538512
• MDR Report Key: 18248150
• Report Number: 2134494-2023-00001
• Device Sequence Number: 20504579
• Product Code: NEU
• UDI-Device Identifier: 00858015005332
• UDI-Public: 00858015005332
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K100994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/09/2023

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: STAR0832
• Device Catalogue Number: STAR0832
• Device Lot Number: 2201007A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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
• Patient Age: 44 YR
• Patient Sex: Unknown