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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 10GA MARKER, RADIOGRAPHIC, IMPLANTABLE

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CARBON MEDICAL TECHNOLOGIES, INC. MAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 10GA MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Catalog Number STAR1031
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
The mammostar biopsy site identifier is a sterile, single-patient use device that is placed into soft tissue during a biopsy procedure to radiographically mark a surgical location. In all cases, the mammostar biopsy site identifier is used in conjunction with a biopsy needle and other accessories to complete the biopsy procedure. One mammostar marker, product code star1031 was placed at the time of initial biopsy. At some point after the marker placement, the patient developed a reaction around the area of the marker. An identical reaction to the one described above was also reported in a second patient at the same facility on the same day. In this case, one mammostar marker, product code star0831 was placed at the time of initial biopsy. See mdr report #: 2134494-2018-00001 for additional information. In both cases, the marker is no longer in place. One patient had the marker surgically removed and the other patient had the marker expel on its own. No testing on the specific device has been conducted as the device was not returned for evaluation. The specific device history record was not reviewed because lot identification information could not be obtained. Biocompatibility testing was conducted as part of the initial qualification of this device and was determined to be non-immunogenic. In addition, appropriate controls are in place for every lot manufactured to ensure that no discrepancies exist before release including packaging and sterilization records. A related experience review was conducted and no other instances of this event have been reported for this catalog number at any other facility. Although it could not be concluded that our device caused or contributed to this event, it has been determined to be reportable pursuant to 21 cfr 803 due to the reported adverse event. As such, we are submitting this medwatch report.
 
Event Description
It was reported that after deployment the marker moved superficial under the skin. This, in the customer opinion, caused an infection.
 
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Brand NameMAMMOSTAR REVOLVE BIOPSY SITE IDENTIFIER, 10GA
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
CARBON MEDICAL TECHNOLOGIES, INC.
1290 hammond road
saint paul MN 55110 5876
Manufacturer (Section G)
CARBON MEDICAL TECHNOLOGIES, INC.
1290 hammond road
saint paul MN 55110 5876
Manufacturer Contact
andrew adams
1290 hammond road
saint paul, MN 55110-5876
6516538512
MDR Report Key7685472
MDR Text Key113895019
Report Number2134494-2018-00002
Device Sequence Number1
Product Code NEU
UDI-Device Identifier00858015005363
UDI-Public00858015005363
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K100994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSTAR1031
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2018
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: 07/13/2018 Patient Sequence Number: 1
Treatment
BIOPSY NEEDLE; OTHER ACCESSORIES
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