MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC HYDROMARK; HYDROMARK BREAST BIOPSY SITE MARKER - NON-CE

Model Number	4010-03-09-T3
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, this event occurred after breast biopsy procedure.After marker plug placement, the plunger became caught in the probe aperture, causing significant resistance.Upon removal of the probe and hydromark, the hydromark plunger was found to be extended.Additionally, the marker could not be placed and was stuck to the plunger.Confirmation with the facility indicated the damaged plunger was not fractured, and no fragments remained inside the body.Procedure was completed.No patient complication.
Additional Manufacturer Narrative
According to the reporter, this event occurred after breast biopsy procedure.After marker plug placement, the plunger became caught in the probe aperture, causing significant resistance.Upon removal of the probe and hydromark, the hydromark plunger was found to be extended.Additionally, the marker could not be placed and was stuck to the plunger.Confirmation with the facility indicated the damaged plunger was not fractured, and no fragments remained inside the body.Procedure was completed.No patient complication.Additional information was provided by the reporter: the examination was terminated without placing the marker into the patient.The doctor stated that after removing the probe and the hydromark together from the patient's body, the aperture was accidentally closed.The device was available for return.Investigation is pending the return of the device.Note: cell d6a documents the date it was attempted to implant the device.According to the reporter, the examination was terminated without placing the marker into the patient.
Additional Manufacturer Narrative
The device was returned for evaluation.Visual inspection revealed that the plunger tip had sheared.No additional anomalies were noted.Based on the investigation, the most likely root cause was determined to be customer failure to follow instructions for use.The instructions for use for this device states: "cause: activating cutter, effect: marker damage, marker migration, device damage and/or difficulty distinguishing marker shape".A good faith effort response indicated: "the doctor stated that when the patient had markers and a hydromark outside the body, she closed the probe's aperture".

• Brand Name: HYDROMARK
• Common Device Name: HYDROMARK BREAST BIOPSY SITE MARKER - 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: 23290016
• Report Number: 3008492462-2025-00027
• Device Sequence Number: 5559300
• Product Code: NEU
• UDI-Device Identifier: 00841911100140
• UDI-Public: (01)00841911100140(11)240924(17)270924(10)F12440263D
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2025

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 Model Number: 4010-03-09-T3
• Device Catalogue Number: CA000413002
• Device Lot Number: F12440263D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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: Unknown