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

Model Number 4010-03-09-T3

Device Problems Material Separation (1562); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/16/2017

Event Type  Injury  

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 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
• Type of Device: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): MICRO STAMPING CORPORATION; 12955 starkey rd.; suite 3700; largo FL 33773
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 6860974
• MDR Text Key: 85907794
• Report Number: 3008492462-2017-00064
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00841911101512
• UDI-Public: (01)00841911101512(17)191112(10)200039656
• 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: user facility
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2016
• 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