BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENCOR NEEDLE GUIDE INSERT

    MDR report key: 5291698 · Received December 11, 2015

    Report

    Report Number
    2020394-2015-01996
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    October 23, 2015
    Report Date
    November 16, 2015
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K040842
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: AS THE LOT NUMBER WAS PROVIDED, A LOT HISTORY REVIEW WAS PERFORMED. THERE WAS NO NON-CONFORMING RECORD ASSOCIATED WITH THE LOT RECORD. THE LOT MET ALL RELEASE CRITERIA. THIS WAS THE FIRST COMPLAINT TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. VISUAL INSPECTION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, A VISUAL INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER; THEREFORE, FUNCTIONAL AND PERFORMANCE EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: MEDICAL RECORDS WERE NOT RETURNED TO THE MANUFACTURER; THEREFORE, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: IMAGES/PHOTOS WERE NOT RETURNED TO THE MANUFACTURER; THEREFORE, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT INSTRUCTIONS FOR USE (IFU) STATES: LORAD/HOLOGIC - THE FIRE FORWARD'S GUIDE RAIL FITS DIRECTLY ONTO THE LORAD/HOLOGIC MOUNTING PINS AND IS SECURED BY THE LORAD THUMBWHEEL. A STERILE, DISPOSABLE NEEDLE GUIDE INSERT (LORAD/HOLOGIC), MODEL ENCLRINSERT, PACKAGED AND SOLD SEPARATELY, IS SNAP-FITTED ONTO THE LORAD STAGE TO PROVIDE A STERILE GUIDE FOR THE ENCOR PROBE TIP. FISCHER/MAMMOTEST - THE ENCOR FIRE FORWARD SLIDE PLATE (FISCHER), MODEL ENCFFF, IS AVAILABLE FOR MOUNTING TO THE FISCHER/MAMMOTEST STEREOTACTIC BIOPSY TABLE. THE REUSABLE ENCOR NEEDLE GUIDE (FISCHER), MODEL ENCFNGUIDE01, AND DISPOSABLE NEEDLE GUIDE INSERT, MODEL ENCFINSERT, PACKAGED AND SOLD SEPARATELY, ARE AVAILABLE TO PROVIDE A STERILE GUIDE FOR THE ENCOR PROBE TIP ON A FISCHER/MAMMOTEST TABLE. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER THE STEREOTACTIC BREAST BIOPSY, THE PATIENT CAME IN FOR PET SCAN AND THERE WAS POSSIBLE INFLAMMATION FOUND IN THE LEFT BREAST. IT WAS FURTHER REPORTED THREE DAYS AFTER THE BIOPSY, 7ML OF CLEAR LIQUID WERE ASPIRATED AND THE PATIENT ALLEGEDLY FORMED A STAPHYLOCOCCUS INFECTION. THE PATIENT WAS PROVIDED MEDICAL TREATMENT FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818248 ENCOR NEEDLE GUIDE INSERT BIOPSY INSTRUMENT KNW BARD PERIPHERAL VASCULAR, INC. VT15E0222

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention