BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOSTAR BIOPSY SITE IDENTIFIER

    MDR report key: 25259369 · Received May 22, 2026

    Report

    Report Number
    2134494-2026-00001
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Report Date
    May 22, 2026
    Manufacturer
    CARBON MEDICAL TECHNOLOGIES
    Product Code
    NEU
    UDI-DI
    00858015005349
    PMA / PMN Number
    K100994
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MAMMOSTAR PRELOADED TISSUE MARKER DEVICE IS A STERILE, NONPYROGENIC, SINGLE USE TISSUE MARKER CONSISTING OF PYROLYTIC CARBON COATED ZIRCONIUM OXIDE DISCRETE MARKER THAT IS VISIBLE ON STANDARD RADIOGRAPHS (X-RAY, MAMMOGRAPHY, FLUOROSCOPY, KV, AND CT) AS WELL AS ULTRASOUND AND MAGNETIC RESONANCE IMAGING (MRI) INCORPORATED INTO LYOPHILIZED BIOMARC DELIVERY GEL. THE MAMMOSTAR PRELOADED TISSUE MARKER IS PLACED INTO SOFT TISSUE DURING OPEN, PERCUTANEOUS, OR ENDOSCOPIC PROCEDURES TO RADIOGRAPHICALLY MARK A SURGICAL LOCATION. THE MAMMOSTAR APPLICATOR SHAFTS ARE MARKED WITH 6 DEPTH INDICATOR BANDS: 3 FOR USE WITH THE SAMPLE MANAGEMENT SYSTEM ON THE PROBE (SOLID BAND LINES MARKED WITH NUMBERED LONGITUDINAL STRIPE IN CORRESPONDING GAUGE COLOR) AND 3 FOR USE WITH THE SAMPLE MANAGEMENT SYSTEM OFF (SOLID BAND MARKED IN CORRESPONDING GAUGE COLORS). EACH DEPTH INDICATOR BAND IS USED TO INDICATE DEPTH CONFIRMATION OF THE APPLICATOR DEVICE WHEN USING MAMMOTOME REVOLVE BIOPSY PROBES. SIDEPORT DEVICES ARE MARKED NEAR THE HANDLE TO INDICATE THE SIDEPORT POSITION TO ALLOW MAMMOSTAR DEPLOYMENT. IT WAS REPORTED THAT DURING A STEREOTACTIC BIOPSY USING MAMMOTOME REVOLVE WITH A SIEMENS UPRIGHT, THE RADIOLOGIST ENCOUNTERED TIP SHEAR WITH (1) STAR0833. THE RADIOLOGIST FIRST USED MMK0801. THE MARKER WAS DEPLOYED, BUT THEY WERE UNABLE TO SEE IT IN THE BREAST. IT COULD HAVE BEEN SUPERIMPOSED BEHIND THE PROBE. THE PHYSICIAN THEN DECIDED TO ADD A SECOND CLIP AND CHOSE TO USE STAR0833. HOWEVER, DURING DEPLOYMENT, THE MARKER BECAME STUCK IN THE CHAMBER, AND WHEN THEY TRIED TO PULL THE DEPLOYMENT DEVICE OUT, IT WAS STUCK IN THE BREAST. AT THE VERY END OF THE MARKER DEPLOYMENT DEVICE, THE WHITE TIP WAS PULLED OFF JUST ENOUGH THAT THE "FORK"- LOOKING END CAUGHT THE BREAST TISSUE, AND THEY WERE UNABLE TO PULL THE DEVICE BACK OUT. THE PHYSICIAN HAD TO MAKE AN ADDITIONAL INCISION ON THE BREAST TO WIDEN THE AREA TO BE ABLE TO PULL THE DEVICE OUT. THE COMPLAINT INVESTIGATION FOR THE MAMMOSTAR BIOPSY SITE IDENTIFIER WAS CONDUCTED BASED ON USER-PROVIDED IMAGES, AS THE RETURNED PRODUCT WAS NOT AVAILABLE FOR EVALUATION. REVIEW OF THE IMAGES DEMONSTRATED THAT THE MAMMOSTAR APPLICATOR HAD BEEN INSERTED INTO THE BIOPSY PROBE WITH THE SIDE PORT ORIENTED TOWARD THE BACK OF THE PROBE RATHER THAN ALIGNED WITH THE PROBE APERTURE. THIS INCORRECT ORIENTATION RESULTED IN DEPLOYMENT OF THE MARKER INTO THE PROBE LUMEN INSTEAD OF THROUGH THE PROBE APERTURE AND INTO THE BIOPSY CAVITY. AS A RESULT, THE DISTAL TIP OF THE APPLICATOR ELEVATED INTO THE APERTURE AND SURROUNDING TISSUE CAVITY, CAUSING THE APPLICATOR TIP TO BECOME CAUGHT ON TISSUE AND PREVENTING NORMAL REMOVAL OF THE PROBE. THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT WAS CONSISTENT WITH IMPROPER ORIENTATION AND USE OF THE APPLICATOR WITHIN THE BIOPSY PROBE. ALTHOUGH IT COULD NOT BE CONCLUDED THAT THIS DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT, IT HAS BEEN DETERMINED TO BE REPORTABLE PURSUANT TO 21 CFR 803 DUE TO THE REPORTED MALFUNCTION. AS SUCH WE ARE SUBMITTING THIS MEDWATCH REPORT. THE INFORMATION CONTAINED HEREIN IS BEING PROVIDED TO THE FDA TO COMPLY WITH REGULATIONS RELATING TO MEDICAL DEVICE REPORTING ADN IS BASED ON INFORMATION SUBMITTED BY OTHERS THAT MAY NOT BE FACTUALLY CORRECT. THIS SUBMISSION DOES NOT CONSTITUTE A DETERMINATION OR ADMISSION THAT A DEVICE HAS MALFUNCTIONED OR THAT A DEVICE IS RELATED TO DEATH, INJURY OR MALFUNCTION.

    Description of Event or Problem · 0

    DURING A STEREOTACTIC BIOPSY USING MAMMOTOME REVOLVE WITH A SIEMENS UPRIGHT, THE RADIOLOGIST ENCOUNTERED TIP SHEAR WITH (1) STAR0833. THE RADIOLOGIST FIRST USED MMK0801. THE MARKER WAS DEPLOYED, BUT THEY WERE UNABLE TO SEE IT IN THE BREAST. IT COULD HAVE BEEN SUPERIMPOSED BEHIND THE PROBE. THE PHYSICIAN THEN DECIDED TO ADD A SECOND CLIP AND CHOSE TO USE STAR0833. HOWEVER, DURING DEPLOYMENT, THE MARKER BECAME STUCK IN THE CHAMBER, AND WHEN THEY TRIED TO PULL THE DEPLOYMENT DEVICE OUT, IT WAS STUCK IN THE BREAST. AT THE VERY END OF THE MARKER DEPLOYMENT DEVICE, THE WHITE TIP WAS PULLED OFF JUST ENOUGH THAT THE "FORK"- LOOKING END CAUGHT THE BREAST TISSUE, AND THEY WERE UNABLE TO PULL THE DEVICE BACK OUT. THE PHYSICIAN HAD TO MAKE AN ADDITIONAL INCISION ON THE BREAST TO WIDEN THE AREA TO BE ABLE TO PULL THE DEVICE OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551578 MAMMOSTAR BIOPSY SITE IDENTIFIER MAMMOSTAR NEU CARBON MEDICAL TECHNOLOGIES STAR0833 2506128A 00858015005349

    Patients

    Seq Age Sex Outcome Treatment
    1