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 Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the reporter, there was a plunger shear with (1) 4010-03-09-t3.The incident occurred during a stereotactic biopsy using the hologic affirm and mammotome revolve.The radiologist informed the patient of the 2 mm retained foreign body.No other complications.No patient symptoms.The spring (foreign body) remains in the breast.The problem occurred during the procedure.The procedure was completed.No patient complications were noted.To date, the latest information received has been that the patient has not received any follow-up/intervention.The device was not returned.The most likley root cause was determined to be customer failure to follow instructions for use.The instructions for use for this device states: "the marker applicator may be sheared off resulting in a piece left behind in the patient.The probability of a tip shear may increase as a result of: · removing or rotating the marker applicator independently from the probe." and "remove the hydromark¿ applicator and the mammotome® revolve¿ biopsy probe together as a single unit from the site".Although no patient/user serious injury occurred, we are reporting this event as this failure mode has been reported in the past.
Event or Problem Description
According to the reporter, there was a plunger shear with (1) 4010-03-09-t3.The incident occurred during a stereotactic biopsy using the hologic affirm and mammotome revolve.The radiologist informed the patient of the 2 mm retained foreign body.No other complications.No patient symptoms.The spring (foreign body) remains in the breast.The problem occurred during the procedure.The procedure was completed.No patient complications were noted.

• 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: 22018609
• Report Number: 3008492462-2025-00015
• Device Sequence Number: 9411791
• Product Code: NEU
• UDI-Device Identifier: 00841911100140
• UDI-Public: (01)00841911100140(11)240620(17)270620(10)F12428105D
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: F12428105D
• 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: 04/16/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2024
• 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