BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCHMARK

    MDR report key: 1532677 · Received November 16, 2009

    Report

    Report Number
    2032230-2009-00007
    Event Type
    Other
    Date Received
    November 16, 2009
    Date of Event
    August 4, 2009
    Report Date
    November 16, 2009
    Manufacturer
    SENORX, INC.
    Product Code
    NEU
    PMA / PMN Number
    K081085
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO HAVE THE MARKER TIP RETURNED FOR EVALUATION, BUT THE SITE WOULD NOT RELEASE IT. AN X-RAY IMAGE OF THE TIP STILL WITHIN THE WAS PROVIDED AND THE IMAGE CLEARLY SHOWED A MARKER TIP. THE TIP APPEARS TO HAVE SEPARATED APPROXIMATELY NEAR THE WELD LINE. TUBING STRETCH AT THE PROXIMAL END OF THE TIP INDICATES THAT THE FAILURE IS NOT ATTRIBUTED TO A WEAK WELD AND THAT EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. STARCH PELLETS WERE VISIBLE AND COMPRESSED WITHIN THE MARKER TIP INNER DIAMETER INCLUDING THE WIREFORM PELLET. A BEND IS VISIBLE AT THE TIP APERTURE. IF A MARKER IS PROPERLY SEATED/ALIGNED INTO AN ENCOR PROBE, THERE IS NOT ENOUGH DISTANCE BETWEEN THE DISTAL TIP OF THE MARKER AND THE PROBE TIP TO STRETCH THE TUBING THIS SEVERELY. THIS INDICATES THAT THE MARKER WAS DEPLOYED MISALIGNED AND NOT FULLY SEATED ONTO THE ENCOR PROBE. THIS MEANS THAT THE DEVICE WAS DEPLOYED WITH THE MARKER APERTURE INSIDE THE PROBE SHAFT AND NOT ALIGNED WITH THE PROBE APERTURE. WHEN THIS OCCURS AND EXCESSIVE PRESSURE IS APPLIED, THE FLEXIBLE MARKER TUBING STRETCHES AND THIS TIP CAN BE PUSHED OUT OF THE PROBE APERTURE. IF THE DEVICE IS FORCEFULLY REMOVED, THE TIP CAN SHEAR OFF AND POTENTIALLY BE LEFT IN THE PATIENT. THIS FAILURE WAS REPLICATED AND THE RESULTS WERE VERY SIMILAR TO THE COMPLAINT DEVICE IN THAT THERE IS A BEND AT THE MARKER APERTURE, AND WELD LINE APPROXIMATELY ALIGNS WITH THE PROXIMAL END OF THE PROBE APERTURE WHICH IS WHERE TIP SEPARATION OCCURS WHEN THE DEVICE IS REMOVED.

    Description of Event or Problem · 1

    A STEREO BIOPSY WAS PERFORMED WITHOUT EVENT ON (B)(6) 2009. THE PATIENT RETURNED TO THE BREAST CENTER ON (B)(6) 2009 BECAUSE WAS CONCERNED BECAUSE SOMETHING KEPT "CATCHING" ON HER BRA. DIGITAL IMAGES SHOWED THE MARKER/APPLICATOR TIP AT THE LOCATION OF THE BIOPSY SITE. DOCTOR MADE A SMALL SKIN NICK AND REMOVED THE MARKER/APPLICATOR PROTRUDING FROM THE SKIN SURFACE. UPON EVALUATION OF THE IMAGES OF THE TIP, THE ROOT CAUSE WAS ATTRIBUTED TO THE DEVICE LIKELY NOT BEING PROPERLY ALIGNED/SEATED WITH THE ENCOR PROBE AT THE TIME OF DEPLOYMENT, CAUSING THE TIP TO PROTRUDE FROM THE APERTURE AND SEVERE WHEN THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCHMARK BIOPSY SITE MARKER NEU SENORX, INC. STMKEC-10GSS POSSIBLY M09042703

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other