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

Model Number	4010-03-09-T3
Medical Device Problem Codes	Material Separation (1562); Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hydromark breast biopsy site marker is used to mark the biopsy site during a percutaneous breast biopsy procedure, visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and mri.The 4010-03-09-t3 hydromark breast biopsy site marker is designed for use with the atec 9 gauge biopsy systems and encore 10 ga directional vacuum-assisted biopsy devices.The device is not available to be returned to the manufacturer for evaluation.However, based on post deployment images, it is possible that the spring at the distal end of the plunger rod remained in the patient breast.Follow up with the customer indicated that the patient is considering a mastectomy, but has yet to decide on a surgical procedure.However, once the patient has decided on a surgical procedure, customer will retain object to return to manufacturer for further analysis.In the information for use it states that when removing the hydromark from the breast, the following steps should be followed.Rotate the hydromark delivery system and the probe 180 degrees to position the delivery system and probe's apertures away from the deployed hydromark marker.Slowly remove the hydromark delivery system and probe as one unit from the breast.Failure to adhere to either of these steps could potentially cause the reported event.Customer has declined further retraining on proper procedure for marker deployment.Due to the potential for a subsequent procedure or other interventional treatment and pursuant to 21 cfr 803, we are submitting this medwatch report.
Event or Problem Description
The sales rep reported that post stereo biopsy and placement of hydromark, the confirmation image showed the clip being oddly shaped.

• 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 45241
• MDR Report Key: 6860974
• Report Number: 3008492462-2017-00064
• Device Sequence Number: 13640944
• Product Code: NEU
• UDI-Device Identifier: 00841911101512
• UDI-Public: (01)00841911101512(17)191112(10)200039656
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130537
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 08/21/2017

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: 11/12/2019
• Device Model Number: 4010-03-09-T3
• Device Catalogue Number: 4010-03-09-T3
• Device Lot Number: 200039656
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 09/13/2017
• 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