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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 STAR1033
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Foreign Body Reaction (1868)
Event Date 04/20/2016
Event Type  Injury  
Manufacturer Narrative
The star1033 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 this event the star1033 biopsy site identifier was used in conjunction with the (b)(4) biopsy system and other disposable equipment. (b)(4) is the legal manufacturer of the (b)(4) biopsy system and distributor of the star1033 biopsy site identifier. This complaint was received from (b)(4) for further investigation. This report is specific only to the star1033 biopsy site identifier analysis. The procedure was completed with no reaction at that time. A superficial tissue reaction was reported several hours after the procedure. The device remains implanted and to our knowledge no further intervention was required and the reaction has resolved. A second reaction identical to the one described in this report also occurred in a second patient at the same facility on the same day. See mdr report #: 2134494-2016-00002 for additional information. This facility has since completed additional biopsies and marker placements without incident. The device was not returned for evaluation. Biocompatibility testing has been conducted and has demonstrated that the device is non-irritating and non-sensitizing. The device history record was reviewed, including packaging and sterilization records, and no discrepancies were found. A related experience review was conducted and no other instances of this event have been reported for this catalog number at any other facility. The above narrative indicates that the reaction was likely not related to the use of the star1033 biopsy site identifier. However it cannot be definitively concluded that this device did not cause or contribute to the event and as such we are submitting this medwatch report.
 
Event Description
The sales rep reported that the patient developed an allergic reaction several hours after the st biopsy. The breast swelled up around the incision area to twice the size of the breast.
 
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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 TECHOLOGIES, INC.
1290 hammond road
saint paul MN 55110 5876
Manufacturer Contact
andrew adams
1290 hammond road
saint paul, MN 55110-5876
6516538512
MDR Report Key5689947
MDR Text Key46257303
Report Number2134494-2016-00001
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 05/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2020
Device Catalogue NumberSTAR1033
Device Lot Number1504118A
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 Received04/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2015
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: 05/31/2016 Patient Sequence Number: 1
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