BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGUIDE NEEDLES

    MDR report key: 24257237 · Received February 4, 2026

    Report

    Report Number
    9611894-2026-00002
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    January 7, 2026
    Report Date
    February 4, 2026
    Manufacturer
    NUCLETRON B.V.
    Product Code
    JAQ
    UDI-DI
    08717213053748
    PMA / PMN Number
    K060349
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT A PIECE OF PLASTIC NEEDLE WAS BROKEN OFF INSIDE THE PATIENT. THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE REPORTED INFORMATION. ON (B)(6) 2026, A PATIENT WAS RECEIVING AN ONCENTRA PROSTATE REAL TIME TREATMENT PROCEDURE. AFTER ALL NEEDLES HAD BEEN INITIALLY PLACED, THE PHYSICIAN REQUESTED ADVANCEMENT OF ONE NEEDLE. INSTEAD OF FULLY REMOVING THE PLASTIC NEEDLE AND RESEATING THE METAL OBTURATOR PRIOR TO REINSERTION, THE METAL OBTURATOR WAS REINSERTED INTO THE PLASTIC NEEDLE WHILE THE NEEDLE REMAINED INSIDE THE PATIENT. AN AUDIBLE "POP" WAS HEARD. UPON REMOVAL OF THE OBTURATOR AND SUBSEQUENT REMOVAL OF THE NEEDLE, IT WAS OBSERVED THAT A PORTION OF THE PLASTIC NEEDLE HAD FRACTURED AND REMAINED INSIDE THE PROSTATE. THE RETAINED FRAGMENT WAS VISUALIZED ON ULTRASOUND IMAGING. THE PROCEDURE WAS IMMEDIATELY ABORTED AND NO RADIATION DOSE WAS DELIVERED TO THE PATIENT. ALL REMAINING NEEDLES WERE REMOVED SUCCESSFULLY WITHOUT ISSUE. THE PATIENT WAS SENT TO THE HOSPITAL FOR EVALUATION. DUE TO THE PATIENT'S PRIOR MEDICAL HISTORY, A PROSTATECTOMY MAY BE CONSIDERED; HOWEVER, AT THE TIME OF THIS REPORT, IT IS UNCLEAR WHETHER THIS WILL OCCUR OR HOW THE RETAINED NEEDLE FRAGMENT WILL ULTIMATELY BE REMOVED. ON (B)(6) 2026, THE PATIENT WAS SENT TO SURGERY TO ATTEMPT TO RETRIEVE THE BROKEN NEEDLE. THE SURGEON WAS UNABLE TO RETRIEVE THE BROKEN PIECE OF THE NEEDLE. THEY HAVE NOW SUGGESTED THAT THE PATIENT BE CHECKED PERIODICALLY MOVING FORWARD TO ENSURE NO FURTHER COMPLICATIONS MIGHT ARISE. THE CUSTOMER THEN STATED THERE ARE NO PLANS TO TRY AND RETREAT THE PATIENT WITH OCP OR EXTERNAL BEAM RIGHT NOW, BUT WILL "WATCH AND WAIT" TO MAKE ANY FURTHER DECISIONS IN THE FUTURE. MANAGING THE PATIENT'S CONDITION IS THE HOSPITAL'S RESPONSIBILITY. BASED ON THE INFORMATION BY THE CUSTOMER, APPROXIMATELY 8 CM OF THE NEEDLE IS LEFT INSIDE THE PATIENT. THE IFU (INSTRUCTIONS FOR USE) EXPLICITLY STATES THAT YOU CANNOT RE-INSERT THE OBTURATOR. THE IFU ALSO ADVISES TO REMOVE ANY REMAINING DEVICE PART(S) FROM THE PATIENT'S BODY. 090695EN PROGUIDE NEEDLE SETS USER MANUAL, SECTION 5.1.4 CONTAINS THE FOLLOWING: WARNING 5.1 TAKE CARE NOT TO PENETRATE CRITICAL ORGANS (E.G. COLON, BLADDER). THEREFORE, DO NOT REINSERT OBTURATORS IN ALREADY INSERTED NEEDLES. IF YOU IGNORE THIS WARNING, THIS CAN RESULT IN INJURY TO THE PATIENT. CAUTION 5.6 DO NOT CONTINUE UNLESS YOU ARE SURE THAT ALL PARTS HAVE BEEN REMOVED FROM THE PATIENT. IF YOU IGNORE THIS CAUTION, YOU CAN CAUSE INJURY AND CLINICAL MISTREATMENT. KNOWN RISKS FOR THIS SCENARIO ARE ALREADY ADDRESSED IN THE EXISTING RISK ANALYSIS DOCUMENT FOR THIS PRODUCT. THE RISK WAS ASSESSED SPECIFICALLY FOR THIS INCIDENT AND WAS CONCLUDED AS MEDIUM (SERIOUS/ REMOTE). THE ROOT CAUSE OF THE BREAKAGE IS USE ERROR.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A PIECE OF PLASTIC NEEDLE WAS BROKEN OFF INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325026 PROGUIDE NEEDLES PROGUIDE SHARP NEEDLE 6FX240M JAQ NUCLETRON B.V. 189637-01 724535 08717213053748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O