MAUDE Adverse Event Report: NUCLETRON B.V. PROGUIDE NEEDLES; PROGUIDE SHARP NEEDLE 6FX240M

Model Number	189637-01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a piece of plastic needle was broken off inside the patient.
Additional Manufacturer Narrative
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.

• Brand Name: PROGUIDE NEEDLES
• Common Device Name: PROGUIDE SHARP NEEDLE 6FX240M
• Manufacturer (Section D): NUCLETRON B.V.; waardgelder 1; veenendaal, 3905 TH; NL 3905 TH
• Manufacturer (Section G): NUCLETRON B.V.; waardgelder 1; veenendaal, 3905 TH; NL 3905 TH
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 24257237
• Report Number: 9611894-2026-00002
• Device Sequence Number: 8309824
• Product Code: JAQ
• UDI-Device Identifier: 08717213053748
• UDI-Public: 08717213053748
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K060349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 189637-01
• Device Lot Number: 724535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown