BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRACHY STAR SEED IMPLANT NEEDLE

    MDR report key: 4349338 · Received December 12, 2014

    Report

    Report Number
    1018233-2014-00352
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Report Date
    October 27, 2016
    Manufacturer
    BARD REYNOSA S.A. DE C.V.
    Product Code
    IWJ
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE BROKE WHILE IN THE PT. THE NEEDLE CONTAINED 6 SEEDS WHEN IT BROKE DURING THE IMPLANT. THE NEEDLE WAS IN THE PT WHEN IT BROKE BUT THEY WERE ABLE TO RETRIEVE BOTH PARTS OF THE NEEDLE AND THE SEEDS WERE STILL IN THE NEEDLE. PER ADDITIONAL INFO RECEIVED THE NEEDLE WAS BEING MANIPULATED BETWEEN THE PT AND GRID WITH A DIDDLER" (TOOL USED TO HELP GUIDE THE NEEDLE TIP TO THE TARGET AREA OF THE PROSTATE). THE NEEDLE WAS IN THE PT'S PERINIUM APPROXIMATELY 1-2 CM WHEN THE BREAKAGE OCCURRED LEAVING 2-3 CM PROTRUDING OUTSIDE OF THE PT'S BODY. THE PHYSICIAN WAS ABLE TO GRASP THE NEEDLE WITH FORCEPS AND PULL OUT THE BROKEN PORTION FROM THE PT. THE DOCTOR PERFORMED A FLUOROSCOPY TO ENSURE THAT NO FRAGMENTS REMAINED IN THE PT. NO FRAGMENTS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808098 BRACHY STAR SEED IMPLANT NEEDLE IWJ BARD REYNOSA S.A. DE C.V. NA REYF1142

    Patients

    Seq Age Sex Outcome Treatment
    1