BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRU PATH BIOPSY NEEDLE

    MDR report key: 1222880 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06114
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE TRU PATH BIOPSY NEEDLE IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE DEVICE HAS BEEN RECEIVED, BUT AN EVAL HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A TRU PATH BIOPSY NEEDLE WAS TO BE USED DURING A PROSTATE BIOPSY PROCEDURE THE DAY PRIOR. ACCORDING TO THE COMPLAINANT, WHEN CHECKING THE DEVICE PRIOR TO THE PROCEDURE, THE INNER STYLET WAS FOUND TO BE BENT. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TRU PATH BIOPSY NEEDLE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU PATH BIOPSY NEEDLE FCG BOSTON SCIENTIFIC CORPORATION M0065001151 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK