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); Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

The hydromark breast biopsy site marker is used to mark tissue 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 confirmed that the spring at the distal end of the plunger rod remained in the patient breast.A patient update is not available at this time.Three (3) attempts were made to gain additional information on the patient.On third attempt, we were notified that the treating physician was out of the office and unable to get further patient information at this time.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 cause the reported event.Due to the potential for a subsequent procedure or other treatment intervention and pursuant to 21 cfr 803, we are submitting this medwatch report.

Event Description

The sales rep reported that during a stereo bx procedure, post sampling a hydromark applicator was inserted into the bx needle to mark site.During deployment of the tissue marker, it appears part of all of the deployment spring came out with the marker (based on post clip images).

• 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: 6659605
• MDR Text Key: 78143096
• Report Number: 3008492462-2017-00044
• Device Sequence Number: 1
• Product Code: NEU
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4010-03-09-T3
• Device Catalogue Number: 4010-03-09-T3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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