BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOPSY SITE MARKER

    MDR report key: 2470738 · Received February 23, 2012

    Report

    Report Number
    1036710-2012-00001
    Event Type
    Other
    Date Received
    February 23, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 6, 2012
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    NEU
    PMA / PMN Number
    K053518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE STERILE SAMPLES WERE RETURNED FOR REVIEW. THE USED DEVICE WAS NOT RETURNED FROM THE CUSTOMER. WITHOUT THE DEVICE USED IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE DEFECT EXPERIENCED. THE TIPS OF THE STERILE SAMPLES RETURNED WERE FINGER PULLED TO ENSURE PROPER GLUING. NO DEFECTS OR DEVIATIONS WERE NOTED DURING THE REVIEW. THE RISK OF MANUFACTURING DEFECTS IS MITIGATED THROUGH INSPECTIONS AND PROCEDURES. A POTENTIAL CAUSE THAT COULD HAVE FACILITATED THE SEPARATION WOULD BE EXCESSIVE FORCE USED BY THE CUSTOMER. IF EXCESSIVE FORCE IS USED THE END COULD SHEAR OFF AS EXPERIENCED. WE WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    AFTER THE SITE MARKER EXPELLED, A +/- "6 O'CLOCK" ROTATION OF THE COLLECTION CHAMBER IS ADVOCATED TO AVOID EXIT OF THE SITE MARKER DURING REMOVAL OF THE DELIVERY SYSTEM. THERE WAS AN IRREGULAR SECTION OF THE DISTAL TIP FOUND. WHEN THE NEEDLE WAS REMOVED THE CUSTOMER FOUND THE MARKER WITH A PLASTIC FRAGMENT CLINGING TO THE COLLECTION CHAMBER. ALL FRAGMENTS WERE RECOVERED AND NO INJURY TO THE PT WAS NOTED, HOWEVER, A POTENTIAL FOR INJURY EXISTS IF FRAGMENTS OF A DEVICE ARE LEFT IN A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOPSY SITE MARKER VMARK BIOPSY SITE MARKER NEU ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES 766411150T 114526VX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other