MAUDE Adverse Event Report: NUCLETRON B.V. ONCENTRA BRACHY; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number	170003-28
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Radiation Burn (1755); Insufficient Information (4580)
Date of Event	08/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported possible catheter reconstruction issue with savi plans.
Additional Manufacturer Narrative
Section h10 additional information.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer inadvertently selected the incorrect reconstruction direction in oncentra brachy while practicing treatment planning.The customer is working with oncentra brachy version 4.5.3 in which the last selected reconstruction direction will be selected automatically when creating a new plan.In addition, the user manual informs the user of an 'independent visual check' on 'correct implant/individual catheter geometry (in image view and/or 3d view)' that needs to be performed to verify the correctness of the catheter reconstruction.The customer has informed elekta that they have implemented a peer review step in their local treatment planning procedure to prevent recurrence of the issue.The product is working as designed and intended.The root cause for this issue was determined to be use error.The hospital confirmed to elekta that there was no serious injury from the patients' skin adverse reactions.

• Brand Name: ONCENTRA BRACHY
• 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: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 12613703
• Report Number: 9611894-2021-00002
• Device Sequence Number: 16474089
• Product Code: JAQ
• UDI-Device Identifier: 08717213052314
• UDI-Public: 08717213052314
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022
• 2 Devices were Involved in the Event: 1 2

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: 170003-28
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown