BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAMMOMARK BIOPSY IDENTIFIER

    MDR report key: 2872509 · Received December 12, 2012

    Report

    Report Number
    3008492462-2012-00050
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 12, 2012
    Manufacturer
    DEVICOR MEDICAL PRODUCTS INC.
    Product Code
    KNW
    PMA / PMN Number
    K082278
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR INSPECTION AND EVAL; 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 MGMT FILE ASSOCIATED WITH OUR MAMMOMARK PRODUCT PORTFOLIO TO INCLUDE TIP SHEAR. OUR MAMMOTOME VACUUM ASSISTED BIOPSY PROBES CONTAIN EXTREMELY SHARP EDGES ALONG THE APERTURE OPENING TO EFFECTIVELY EXCISE TISSUE. MISALIGNMENT OF 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 WITHIN THE INSTRUCTIONS FOR USE: WARNING: FAILURE TO ALIGN THE MAMMOMARK APPLICATOR AS SPECIFIED MAY RESULT IN IMPROPER DEPLOYMENT OF THE COLLAGEN PLUG AND POSSIBLE TIP SHEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT DURING A BREAST BIOPSY PROCEDURE, AFTER REMOVING THE PROBE AND MARKER AS ONE SINGLE INSERTION, THE PHYSICIAN NOTICED THAT THE TIP HAD SHEARED OFF INTO THE PT'S BREAST. THE PHYSICIAN WAS UNSUCCESSFUL IN RETRIEVING THE TIP AND IT REMAINS INSIDE THE PT. PHYSICIAN WILL WAIT FOR THE PATHOLOGY REPORT BEFORE MAKING A DECISION ON REMOVING THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMOMARK BIOPSY IDENTIFIER TISSUE MARKER KNW DEVICOR MEDICAL PRODUCTS INC. MAM3008 F11215309D1

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK