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	06/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the reporter, this event happened after clip placement/biopsy site marking.Prior to the case, a recommendation was given to dr.(b)(6) for vacuuming the cavity before deploying the marker and not to close the probe aperture after marker deployment to prevent plunger shear.During the procedure, it was recommended to dr.(b)(6) to do a standard vacuum with encor vab system.The doctor declined and proceeded with marker deployment.Turn the probe aperture 180 degree from the marker placement.Dr.(b)(6) also preferred to close the probe aperture despite being advised and explanation was given.While the doctor closed the aperture of the probe, there was a cracking sound heard.The doctor removed the probe and marker as one from the patient's body.Post marker image was completed only after the probe and marker was removed from patient's body.Post marker image showed open coil marker was deployed successfully but a circle shape of plunger rod seen next to the marker.Patient was informed regarding the plunger rod and awaiting for the specimen result to decide the next of action.Procedure was completed.No patient complication.Additional information from the reporter: the patient is undergoing the removal procedure on (b)(6) 2025.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".Plunger shears are a potential occurrence for the hydromark¿ breast biopsy site marker (or marker) when the device is not used in accordance with the instructions for use and/or the deployment guide that accompanies the device.For example, when the user does not release pressure from the plunger after marker deployment or if the aperture is closed with the marker applicator still inside the needle/probe.Biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the applicator shaft or closing the aperture after marker deployment creates the possibility of the applicator or plunger catching one of these edges and shearing off.The instruction for use and deployment guide, provided with the device, must be followed to avoid the applicator/ plunger from shearing off.Components of the applicator are classified as "limited patient contact" and qualified for the intended use during the procedure.Applicator materials are considered medical-grade but have not been evaluated for permanent implantation.(the 4010-03-09-tx spring-design plunger material composition is 302 stainless steel.) we recommend removal of the sheared materials.As with any implanted device, the implant site should be monitored for any signs of irritation or reaction following the surgical procedure.
Event or Problem Description
According to the reporter, this event happened after clip placement/biopsy site marking.Prior to the case, a recommendation was given to dr.(b)(6) for vacuuming the cavity before deploying the marker and not to close the probe aperture after marker deployment to prevent plunger shear.During the procedure, it was recommended to dr.(b)(6) to do a standard vacuum with encor vab system.The doctor declined and proceeded with marker deployment.Turn the probe aperture 180 degree from the marker placement.Dr.(b)(6) also preferred to close the probe aperture despite being advised and explanation was given.While the doctor closed the aperture of the probe, there was a cracking sound heard.The doctor removed the probe and marker as one from the patient's body.Post marker image was completed only after the probe and marker was removed from patient's body.Post marker image showed open coil marker was deployed successfully but a circle shape of plunger rod seen next to the marker.Patient was informed regarding the plunger rod and awaiting for the specimen result to decide the next of action.Procedure was completed.No patient complication.

• 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: 22565926
• Report Number: 3008492462-2025-00021
• Device Sequence Number: 3904116
• Product Code: NEU
• UDI-Device Identifier: 00841911100140
• UDI-Public: (01)00841911100140(11)250226(17)280226(10)F12508117D
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K210752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 07/22/2025

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: F12508117D
• 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: 06/24/2025
• Initial Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2025
• 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
• Patient Sex: Unknown