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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)
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.
 
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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 Key6860974
MDR Text Key85907794
Report Number3008492462-2017-00064
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 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 Received09/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/12/2019
Device Model Number4010-03-09-T3
Device Catalogue Number4010-03-09-T3
Device Lot Number200039656
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2016
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: 09/13/2017 Patient Sequence Number: 1
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