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

Model Number	4010-03-09-T3
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hydromark breast biopsy site marker is made of a resorbable hydrogel that expands with fluid and is then resorbed.The hydrogel material is visible under ultrasound.Embedded in the hydrogel is a coiled metallic wire that will be permanently visible under x-ray and mri when the hydrogel is resorbed.The hydromark biopsy site marker is a permanent implant and is not intended to be removed unless the marked tissue is determined to require surgical removal.According to the reporter, this event happened after clip placement/biopsy site marking.The spring of the marker was caught in the aperture and damaged.Spring extended but probably not broken.The procedure was completed.No patient complications.Good faith efforts were performed and the reporter clarified the following information: there was no additional intervention or surgery conducted.The aperture was closed after placement of device.The revolve st biopsy device was examined, and the marker placement in patient body was confirmed by mammography.There were no metal fragments or other objects around the marker.One 4010-03-09-t3 hydromark and one mst1009 probe were returned and evaluated.The 4010-03-09-t3 was found to have the spring on the plunger sheared.The mst1009 had no observable aperture damage and no signs of the sheared spring.The root cause was determined to be customer failure to follow instructions for use (ifu).The customer provided the following information as a good faith effort response: "the aperture was closed after placement".The instructions for use (ifu) state: "cause: activating cutter" and "effect: marker damage, marker migration, device damage, and/or difficulty distinguishing marker shape." although no patient/user 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, this event happened after clip placement/biopsy site marking.The spring of the marker was caught in the aperture and damaged.Spring extended but probably not broken.The procedure was completed.No patient complications.
Additional Manufacturer Narrative
The initial report was submitted 18-jul-2023.The catalog # was left blank, the incorrect primary unique device identifier (udi) # and incorrect d9 returned to manufacturer date was provided in the initial report.The following cells were corrected in this follow up #1 report: d4 catalog #, d4 primary unique device identifier (udi) # and d9 returned to manufacturer.

• Brand Name: MAMMOTOME HYDROMARK
• Common Device Name: HYDROMARK BREAST BIOPSY SITE MARKER
• 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, mx 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 19773547
• Report Number: 3008492462-2024-00009
• Device Sequence Number: 18188024
• Product Code: NEU
• UDI-Device Identifier: 00841911100140
• UDI-Public: (01)00841911100140(10)F12319391D(11)230417(17)260417
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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 Expiration Date: 04/17/2026
• Device Model Number: 4010-03-09-T3
• Device Catalogue Number: CA000413002
• Device Lot Number: F12319391D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2023
• 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