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U.S. Department of Health and Human Services

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

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DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK BREAST BIOPSY SITE MARKER BIOPSY SITE IDENTIFIER Back to Search Results
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).
 
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Brand NameHYDROMARK BREAST BIOPSY SITE MARKER
Type of DeviceBIOPSY 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 Key6659605
MDR Text Key78143096
Report Number3008492462-2017-00044
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130537
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
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 Received06/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number4010-03-09-T3
Device Catalogue Number4010-03-09-T3
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2017
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 Treatment Data
Date Received: 06/22/2017 Patient Sequence Number: 1
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