MAUDE Adverse Event Report: NUCLETRON B.V. PROGUIDE 6FX240 S (72 PCS.); SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer was concerned of a risk of biological contamination after the catheter broke inside the patients body.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer was concerned of a risk of biological contamination after the catheter broke inside the patients body.The returned materials, treatment report and provided data were investigated, and it was ascertained that the breakage occurred at around 140 mm from the proguide needle connector end, approximatey 2 cm into the patient.The location of the breakage corresponds with the three obstruction errors that occurred during the treatment (in channel 22), located at the top of the implant.The treatment report shows that the obstruction errors were cleared and the treatment was completed in full.The broken needle was inspected with a digital microscope and there are several fabric (suture) strands visible on the inside and outside of the needle that are partly embedded in the plastic of the needle at the location of the breakage.There is also what appears to be a channel left by the suture needle and a hole and cut at the other side of the needle.Most likely the suture needle and thread went straight though the proguide needle.The thread passing the needle resulted in a check cable obstruction during the treatment.The check cable apparently pushed the thread away, clearing the path for the second check cable run.The same thing happened when the source went into the needle, that cleared after two attempts and the treatment in the needle was completed.Wipe tests that were performed on the source and check cable after the treatment as well as the inner side of the transfer tube did not show any sign of contamination with bodily fluids.This indicates that the proguide needle was still mostly intact during the treatment procedure and got cut and split when the suture thread was removed after the treatment and the implant was removed from the patient.The other needles in the implant as well as the needles in a sealed pouch from the same batch were inspected but no deviations were found.To simulate the breakage, one of the unused needles was broken in two pieces by bending and over-straightening (a cause of breakage that is known to occur when the obturator is not inserted properly and hard tissue is met during insertion) but the resulting breakage pattern is notably different from the returned needle.It is therefore concluded that the issue occurred due to use error which resulted in perforation of the proguide needle with the suture needle and subsequent breakage when the implant was removed.The treatment was delivered as planned and the broken piece of proguide needle was removed without further implications.

• Brand Name: PROGUIDE 6FX240 S (72 PCS.)
• Common Device Name: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• 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: 23038108
• Report Number: 9611894-2025-00001
• Device Sequence Number: 9477094
• Product Code: JAQ
• UDI-Device Identifier: 08717213054523
• UDI-Public: 08717213054523
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2024
• 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: Other
• Patient Sex: Unknown