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

Model Number	4010-03-09-T1
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	10/29/2024
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, the patient required a biopsy as a result of a routine pre-operative screening mammogram before breast reduction procedure.The event happened after clip placement/biopsy site marking.The event occurred using stereotactic (st) deployment, using hologic atec vacuum assisted biopsy (vab).The marker deployed on (b)(6) 2024 successfully however, after a couples of days, redness, pain and swelling was observed by the patient.Prior to deployment, iron was disclosed as an allergy.The procedure was completed.During the patient's breast reduction procedure on (b)(6) 2024, hook wire was placed to ensure the marker clip was removed.Marker removal was not the goal of the surgery.The device was not returned for evaluation.The root cause was traced to non-device related factors.Based on the information available it is most likely the adverse event was related to the patient condition.
Event or Problem Description
According to the reporter, the patient required a biopsy as a result of a routine pre-operative screening mammogram before breast reduction procedure.The event happened after clip placement/biopsy site marking.The event occurred using stereotactic (st) deployment, using hologic atec vacuum assisted biopsy (vab).The marker deployed on (b)(6) 2024 successfully however, after a couples of days, redness, pain and swelling was observed by the patient.Prior to deployment, iron was disclosed as an allergy.The procedure was completed.During the patient's breast reduction procedure on (b)(6) 2024, hook wire was placed to ensure the marker clip was removed.Marker removal was not the goal of the surgery.

• 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, mx 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 20864127
• Report Number: 3008492462-2024-00010
• Device Sequence Number: 15609087
• Product Code: NEU
• UDI-Device Identifier: 00841911102182
• UDI-Public: (01)00841911102182(10)F12333438D(11)230814(17)260814
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K210752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2024

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: 08/14/2026
• Device Model Number: 4010-03-09-T1
• Device Catalogue Number: CA000413003
• Device Lot Number: F12333438D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2023
• 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