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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOMARK BIOPSY SITE IDENTIFIER

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DEVICOR MEDICAL PRODUCTS, INC. MAMMOMARK BIOPSY SITE IDENTIFIER Back to Search Results
Model Number MAM3008
Device Problem Device Damaged by Another Device (2915)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/06/2018
Event Type  Injury  
Manufacturer Narrative
The mammomark biopsy site identifier is intended for use after an open surgical or percutaneous breast biopsy procedure to the biopsy site. The device is not available for analysis, which precludes a full investigation and analysis of the root cause. Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue. Removing the marker delivery system separately from the probe aperture once the spring is exposed creates the possibility of it catching on one of these edges. As a mitigation step to address this risk, we provide instructions within the instructions for use: directions: remove the delivery system and mammotome probe together as a single unit from the site, properly dispose and obtain images to confirm marker placement. Based on the patient consequence of an unintended piece of the device in the biopsy site, and the additional surgical procedure to remove, and pursuant to 21 cfr 803, we are submitting this medwatch report.
 
Event Description
It was reported by the sales rep that during the procedure, post right-breast stereotactic biopsy, there was a failure of the tissue marker to deploy correctly. The plastic sheath broke off in the breast. The retained piece was visualized during post imaging.
 
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Brand NameMAMMOMARK
Type of DeviceBIOPSY SITE IDENTIFIER
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS, INC.
300 e-business way
fifth floor
cincinnati OH 45241
Manufacturer (Section G)
DEVICOR MEDICAL PRODUCTS DE MEXICO
sor juana ines de la cruz
#20152 4-b, parque industrial
tijuana, baja california 22440
MX 22440
Manufacturer Contact
shawna rose
300 e-business way
fifth floor
cincinnati, OH 45241
5138649178
MDR Report Key7361702
MDR Text Key103173195
Report Number3008492462-2018-00023
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2019
Device Model NumberMAM3008
Device Catalogue NumberMAM3008
Device Lot NumberF11731392D
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2017
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: 03/22/2018 Patient Sequence Number: 1
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