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

Model Number	4010-05-10-T3
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, this event occurred before breast biopsy procedure.In this facility, only the hydromark was pulled out first after marker placement, not together with the probe.The procedure after hydromark placement has not yet been changed.After marker placement, only the hydromark is removed.Then close the probe aperture and pull out the probe the process is carried out as above.Therefore, the hydrogel was cut when the probe aperture was closed.The facility explained that no fragment remained inside the patient body.Procedure was completed.No patient complication.
Additional Manufacturer Narrative
According to the reporter, this event occurred before breast biopsy procedure.In this facility, only the hydromark was pulled out first after marker placement, not together with the probe.The procedure after hydromark placement has not yet been changed.After marker placement, only the hydromark is removed.Then close the probe aperture and pull out the probe the process is carried out as above.Therefore, the hydrogel was cut when the probe aperture was closed.The facility explained that no fragment remained inside the patient body.Procedure was completed.No patient complication.After evaluation of the complaint information received it was confirmed that a tip shear occurred.The details of the complaint stated the following in the event description" in this facility, only the hydromark was pulled out first after marker placement, not together with the probe" and "after marker placement, only the hydromark is removed." the 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 injury occurred, we are reporting this event as this failure mode has been reported in the past.

• Brand Name: HYDROMARK
• Common Device Name: HYDROMARK BREAST BIOPSY SITE MARKER - 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
• MDR Report Key: 21536271
• Report Number: 3008492462-2025-00013
• Device Sequence Number: 20594704
• Product Code: NEU
• UDI-Device Identifier: 00841911102434
• UDI-Public: (01)00841911102434(10)F12403459D(11)231030(17)261030
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203097
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: 4010-05-10-T3
• Device Catalogue Number: CA000520002
• Device Lot Number: F12403459D
• 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: 02/07/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2024
• 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
• Patient Sex: Unknown