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

Model Number 170003-28

Device Problems Product Quality Problem (1506); Use of Device Problem (1670)

Patient Problems Radiation Burn (1755); Insufficient Information (4580)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

The customer reported possible catheter reconstruction issue with savi plans.

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
• 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: 12613703
• MDR Text Key: 280932393
• Report Number: 9611894-2021-00002
• Device Sequence Number: 1
• Product Code: JAQ
• UDI-Device Identifier: 08717213052314
• UDI-Public: 08717213052314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 170003-28
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2021
• 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