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

Model Number	4010-02-15-T4
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Date of Event	03/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and mri.It was reported by sales rep that after successful deployment of the hydromark ( 4010-02-15-t4) an artifact was seen on the post mamogram.This incident has been recorded in complaint #(b)(4).An investigation was performed and based on observed conditions, a detailed analysis was conducted in the manufacturing assembly line to determine what could have potentially be caused this event.During the review of the operations of hydromark line, it was found that the line works according to what is indicated in the procedures (mp's).All product inspections and manufacture documentation of the hydromark process line is within specification and in accordance to all required process documentation.Manufacturing process and dhr have been reviewed all testing performed were within specification for the specified lot.Devicor could not conclude that our device caused or contributed to this event, due to the allegation of an artifact seen on the post mamogram this has been determined to be reportable pursuant to 21 cfr 803.As such, we are submitting this medwatch report.
Event or Problem Description
It was reported by sales rep that after successful deployment of the hydromark ( 4010-02-15-t4) an artifact was seen on the post mamogram.This incident has been recorded in complaint #(b)(4).Devicor could not conclude that our device caused or contributed to this event, due to the allegation of an artifact seen on the post mamogram this has been determined to be reportable pursuant to 21 cfr 803.As such, we are submitting this medwatch report.

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• Common Device Name: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e. business way; fifth floor; cincinnati, oh
• MDR Report Key: 9965873
• Report Number: 3008492462-2020-00006
• Device Sequence Number: 19356012
• Product Code: NEU
• UDI-Device Identifier: 10841911100116
• UDI-Public: (01)10841911100116(17)220718(10)F11931422D
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2020

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: 07/18/2022
• Device Model Number: 4010-02-15-T4
• Device Catalogue Number: 4010-02-15-T4
• Device Lot Number: F11931422D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other