MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOMARK; MAMMOMARK BIOPSY SITE IDENTIFIER 8G - BOWTIE - NON-CE

Model Number	MMK0801
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the reporter, there was a tip shear incident.Account was using a mammotome 8g probe with an affirm system.The radiologist finished taking samples and dialed back 10mm in preparation to place the marker.The radiologist had a hard time deploying the marker, noticing that there was resistance.They also noticed that it was difficult to pull the probe and marker out of the breast.The tech reports that the probe and the introducer were removed from the breast together.Marker tip was discovered inside of the breast upon post-biopsy mammogram.Update: upon calling the account for additional information, it was made known that the pathology from the biopsy came back positive and the patient will be going to surgery to remove the tissue.The problem occurred during the procedure.The procedure was completed with the reported marker.No patient complications were noted.Additional information was provided by the reporter: the tip was left in the patient post procedure and the patient was aware.The biopsy was positive and patient has a surgical consult scheduled.The cutter was not closed while the mammomark was inside the probe.The device was not returned for evaluation.Based on available information and user feedback, the most likely root cause was determined to be customer failure to follow the instructions for use (ifu).The ifu clearly states: "caution: do not insert beyond appropriate band or tip damage may occur." "caution: do not activate the probe cutter or other clinical functions while a marker is inserted in the probe.Take care to completely remove the marker out of the probe before activating any of the holster's clinical functions." failure to adhere to these precautions may have contributed to the reported issue.If any new information becomes available, the complaint will be reassessed accordingly.
Event or Problem Description
According to the reporter, there was a tip shear incident.Account was using a mammotome 8g probe with an affirm system.The radiologist finished taking samples and dialed back 10mm in preparation to place the marker.The radiologist had a hard time deploying the marker, noticing that there was resistance.They also noticed that it was difficult to pull the probe and marker out of the breast.The tech reports that the probe and the introducer were removed from the breast together.Marker tip was discovered inside of the breast upon post-biopsy mammogram.Update: upon calling the account for additional information, it was made known that the pathology from the biopsy came back positive and the patient will be going to surgery to remove the tissue.The problem occurred during the procedure.The procedure was completed with the reported marker.No patient complications were noted.

• Brand Name: MAMMOMARK
• Common Device Name: MAMMOMARK BIOPSY SITE IDENTIFIER 8G - BOWTIE - NON-CE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; tijuana, bc 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way; fifth floor; cincinnati, OH 45241 ; 5138649047
• MDR Report Key: 23759254
• Report Number: 3008492462-2025-00030
• Device Sequence Number: 21315712
• Product Code: NEU
• UDI-Device Identifier: 00841911101376
• UDI-Public: (01)00841911101376(17)260827(10)F12508368D
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

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 Expiration Date: 08/27/2026
• Device Model Number: MMK0801
• Device Lot Number: F12508368D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2025
• 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: Required Intervention; Other
• Patient Sex: Unknown