BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU PATH BIOPSY NEEDLE

    MDR report key: 1375567 · Received May 5, 2009

    Report

    Report Number
    3005099803-2009-02246
    Event Type
    Injury
    Date Received
    May 5, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 7, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    PMA / PMN Number
    K050120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A TRUPATH PROSTATE BIOPSY NEEDLE WAS USED DURING A TRANSRECTAL PROSTATE BIOPSY PROCEDURE IN 2009. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE PATIENT WAS PRESCRIBED PROPHYLACTIC CIPRO PRIOR TO THE PROCEDURE. THE PATIENT REPORTED TO THE PHYSICIAN THE FOLLOWING MONTH, STATING HE WAS HAVING BURNING DURING URINATION, SWEATING, AND CHILLS. THE PHYSICIAN PRESCRIBED SEPTRA TO TREAT A SUSPECTED INFECTION. ACCORDING TO THE COMPLAINANT, THE PATIENT'S SYMPTOMS CONTINUED TO DECLINE AND HE WAS ADMITTED TO THE HOSPITAL FOR ADMINISTRATION OF INTRAVENOUS ANTIBIOTICS. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL AFTER FOUR DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRU PATH BIOPSY NEEDLE FCG BOSTON SCIENTIFIC CORPORATION M0065001151 11808082

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R