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

Device Problems Computer Software Problem (1112); Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

Oncentra brachy offers applicator modelling functionality, which aids the end-user in the reconstruction of an entire applicator geometry.In a very specific workflow using the bending functionality, catheter reconstruction points are erroneously added to the existing catheter reconstruction.These erroneously placed reconstruction points create a double kink in the reconstruction that, if unnoticed, could result in a difference between the planned and delivered dose.

Event Description

During elekta's verification of development of a new functionality for the new oncentra brachy (ocb) release, elekta found a possible issue in the catheter bending functionality which may be present in version 4.0 and newer versions.It appears that in certain situations an incorrect catheter reconstruction may be produced which may be difficult to identify as a user.

Manufacturer Narrative

Oncentra brachy offers applicator modelling functionality, which aids the end-user in the reconstruction of an entire applicator geometry.In a very specific workflow using the bending functionality, catheter reconstruction points are erroneously added to the existing catheter reconstruction.These erroneously placed reconstruction points create a double kink in the reconstruction that, if unnoticed, could result in a difference between the planned and delivered dose.The root cause is a software defect in the catheter bending functionality, which is available when using applicator or implant modeling.This issue has been found internally during the development of new functionality.No customer complaints have been reported to the manufacturer about this specific issue since the introduction of the product.An important field safety notice was sent to all affected customers from 25 november 2022 (elekta reference # fca-nu-0008).A software update will be released addressing the defect which is estimated may 2023.

• Brand Name: ONCENTRA BRACHY
• Type of Device: 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: 15769323
• MDR Text Key: 303659776
• Report Number: 9611894-2022-00001
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K132816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1