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	06/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, the event occurred after the procedure.There was difficult placement of the hydromark.The hydromark remains in the bard needle.The spring gets stuck behind the needle opening.This makes it difficult to remove the system.A piece of the spring remained in the chest.The procedure was completed with another device.No patient consequences reported.
Additional Manufacturer Narrative
According to the reporter, the event occurred after the procedure.There was difficult placement of the hydromark.The hydromark remains in the bard needle.The spring gets stuck behind the needle opening.This makes it difficult to remove the system.A piece of the spring remained in the chest.The procedure was completed with another device.No patient consequences reported.Additional information was provided by the reporter: according to the doctors, there was no risk to the patient.The revolve device was checked and tested and shows no defects.No additional interventions have been done or planned with the hydromarks of this lot.The device was not returned.The most likely 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".

• 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: 22508292
• Report Number: 3008492462-2025-00022
• Device Sequence Number: 18327081
• Product Code: NEU
• UDI-Device Identifier: 00841911102199
• UDI-Public: (01)00841911102199(11)241108(17)271108(10)F12446304D
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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: CA000413004
• Device Lot Number: F12446304D
• 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: 06/23/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/27/2024
• 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