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

Model Number 4010-02-15-T4

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 03/19/2020

Event Type  Injury  

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 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
• Type of Device: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e. business way; fifth floor; cincinnati, oh
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; parque industrial, 22440 ; MX 22440
• Manufacturer Contact: jack cummings ; 300 e business way; fifth floor; cincinnati, oh
• MDR Report Key: 9965873
• MDR Text Key: 194136562
• Report Number: 3008492462-2020-00006
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 10841911100116
• UDI-Public: (01)10841911100116(17)220718(10)F11931422D
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other