BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMARK BIOPSY IDENTIFIER

    MDR report key: 2860084 · Received November 21, 2012

    Report

    Report Number
    3008492462-2012-00045
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 21, 2012
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    NEU
    PMA / PMN Number
    K082278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR INSPECTION AND EVALUATION; THEREFORE, A DEFINITIVE CONCLUSION COULD NOT BE REACHED REGARDING THIS SPECIFIC EVENT. BASED ON OUR KNOWLEDGE OF THE DEVICE DESIGN AND ITS PRESCRIBED USE, WE HAVE DEVELOPED A COMPREHENSIVE RISK MANAGEMENT FILE ASSOCIATED WITH OUR MAMMOMARK PRODUCT PORTFOLIO. THE MOST LIKELY SCENARIO IS THAT THE USER REMOVED THE MARKER APPLICATOR SEPARATELY FROM THE BIOPSY PROBE. TIP SHEAR HAS BEEN IDENTIFIED AS A POTENTIAL RISK WHENEVER THE APPLICATOR TUBE IS REMOVED THROUGH THE BIOPSY PROBE. OUR MAMMOTOME VACUUM ASSISTED BIOPSY PROBES CONTAIN EXTREMELY SHARP EDGES ALONG THE APERTURE OPENING TO EFFECTIVELY EXCISE TISSUE. REMOVING THE APPLICATOR TUBE CREATES THE POSSIBILITY OF THE APPLICATOR CATCHING ON ONE OF THESE EDGES AND SHEARING. AS A MITIGATION STEP TO ADDRESS THIS RISK, WE PROVIDE CONTRAINDICATION LANGUAGE AND INSTRUCTION WITHIN THE INSTRUCTION FOR USE: WARNING: FAILURE TO ALIGN THE MAMMOMARK APPLICATOR AS SPECIFIED MAY RESULT IN IMPROPER DEPLOYMENT OF THE COLLAGEN PLUG AND POSSIBLE TIP SHEAR. INSTRUCTION #10: REMOVE THE MAMMOMARK APPLICATOR AND THE MAMMOTOME BIOPSY PROBE TOGETHER AS A SINGLE UNIT FROM THE SITE AND OBTAIN IMAGES TO CONFIRM MARKER PLACEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW UP POST MAMMOGRAM IMAGE, THE APPLICATOR TIP OF THE MARKER WAS NOTED ADJACENT TO THE BIOPSY CLIP. THE PHYSICIAN REPORTED THAT THE MARKER WAS EXTENDING THROUGH THE APERTURE AND THE CLIP WOULD NOT DEPLOY AND HE WAS UNABLE TO RETRACT THE MARKER DURING THE PROCEDURE. PATIENT REQUIRED HAVING THE TIP REMOVED FROM HER BREAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOMARK BIOPSY IDENTIFIER TISSUE MARKER NEU DEVICOR MEDICAL PRODUCTS INC. MAM3008 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK