MAUDE Adverse Event Report: Devicor Medical Products Inc HydroMARK; HydroMark Breast Biopsy Site Marker-Non CE

Model Number	4010-05-10-T3
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter,  there were deployment issues with the hydromark during a prone procedure using the revolve 10g probe.The first marker did not deploy and confirmed that it was not stuck inside the applicator.Marker 1 deployment steps confirmed by the customer: 1.The aperture was rotated to 6:00, and the arrow was also pointing at 6:00.2.The tech was not in the room, but she suspects that the marker applicator was not advanced until a definitive stop was felt.3.The aperture was fully opened.4.The plunger was pressed until a click was heard.5.The probe and marker applicator were rotated 180 degrees away from deployment, and both were removed together.After this, another marker was inserted, which potentially led to a plunger shear.Following the procedure, a plastic fragment was discovered at the patient's biopsy site and was subsequently removed.Marker 2 deployment steps confirmed by the customer: 1.The aperture was rotated to 6:00, and the arrow was also pointing at 6:00.2.The marker applicator was advanced until a definitive stop was felt.3.The aperture was fully opened.4.The plunger was pressed until a click was heard.5.The probe and marker applicator were rotated 180 degrees away from deployment, and both were removed together.Post-procedure images reveal a small, fragmented piece of metal and a fragmented plastic piece.The radiologist removed the fragmented plastic piece/applicator tip from the patient in the biopsy suite at the conclusion of the procedure.No adverse reactions were reported.The problem occurred after the procedure.The procedure was completed with another marker.Patient complications were noted.The fragmented plastic piece/applicator tip broke off inside the breast.No adverse reactions were reported.
Additional Manufacturer Narrative
According to the reporter,  there were deployment issues with the hydromark during a prone procedure using the revolve 10g probe.The first marker did not deploy and confirmed that it was not stuck inside the applicator.Marker 1 deployment steps confirmed by the customer: 1.The aperture was rotated to 6:00, and the arrow was also pointing at 6:00.2.The tech was not in the room, but she suspects that the marker applicator was not advanced until a definitive stop was felt.3.The aperture was fully opened.4.The plunger was pressed until a click was heard.5.The probe and marker applicator were rotated 180 degrees away from deployment, and both were removed together.After this, another marker was inserted, which potentially led to a plunger shear.Following the procedure, a plastic fragment was discovered at the patient's biopsy site and was subsequently removed.Marker 2 deployment steps confirmed by the customer: 1.The aperture was rotated to 6:00, and the arrow was also pointing at 6:00.2.The marker applicator was advanced until a definitive stop was felt.3.The aperture was fully opened.4.The plunger was pressed until a click was heard.5.The probe and marker applicator were rotated 180 degrees away from deployment, and both were removed together.Post-procedure images reveal a small, fragmented piece of metal and a fragmented plastic piece.The radiologist removed the fragmented plastic piece/applicator tip from the patient in the biopsy suite at the conclusion of the procedure.No adverse reactions were reported.The problem occurred after the procedure.The procedure was completed with another marker.Patient complications were noted.The fragmented plastic piece/applicator tip broke off inside the breast.No adverse reactions were reported.The device was not returned for evaluation.Based on available information and user feedback, the most likely root cause was determined to be customer failure to follow the instructions for use (ifu).The ifu clearly 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.- failure to align the hydromark applicator device as specified.- failure to release pressure from the plunger and not allowing the plunger to retract as specified.- inserting the marker applicator beyond the appropriate depth mark as indicated in the eifu.- diagnostic tissue remaining in the biopsy probe needle during marker insertion and deployment.Significant resistance met during the advancement of the hydromark applicator device prior to reaching the appropriate indicator band may require additional intervention.(remove the marker applicator and biopsy probe as a single unit from the site, clearing the probe aperture of any tissue obstruction, and resuming procedure.) - using the hydromark applicator device with an incompatible biopsy probe." this report is submitted in accordance with mdr reporting requirements based on information currently available to the manufacturer.The investigation has not identified evidence confirming a device malfunction, and no adverse event or patient injury occurred.The event is being reported because a recurrence under similar circumstances could have the potential to result in serious injury.

• 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 ; +1(513)864-9047
• MDR Report Key: 50174848
• Report Number: 3008492462-2026-00013
• Device Sequence Number: 10035038
• Product Code: NEU
• UDI-Device Identifier: 00841911103677
• UDI-Public: (01)00841911103677(11)260427(17)290427(10)F12623345D
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K203097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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: 4010-05-10-T3
• Device Catalogue Number: CA000520005
• Device Lot Number: F12623345D
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2026
• 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