MAUDE Adverse Event Report: NUCLETRON MICROSELECTRON MHDR; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number DIGITAL

Device Problems Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problem Erythema (1840)

Event Date 11/21/2014

Event Type  No Answer Provided  

Event Description

The patient visited the breast surgeon for skin redness, two weeks after a savi applicator breast treatment.The surgeon reviewed the treatment plan and determined that the catheter was reconstructed backwards with the dose heavily weighted toward the connector end of the savi applicator.This results in a dose given at certain proximity to the skin which can cause skin redness.Nucletron did not receive data to determine the severity of the event.The savi applicator was connected to a nucletron microselectron afterloader and the treatment planning was performed with nucletron oncentra brachytherapy treatment planning software.

Manufacturer Narrative

The user was consulted on how such a case can be avoided.The user was advised this can be prevented with features available for this in oncentra brachy.No specific details were provided by the user to perform further analysis.No information received from hospital.

• Brand Name: MICROSELECTRON MHDR
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON; waardgelder 1; veenendaal, ; NL
• Manufacturer Contact: linac house; fleming way; crawley, west sussex RH10 -9RR
• MDR Report Key: 4332511
• MDR Text Key: 15321846
• Report Number: 9611894-2014-00004
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092804
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIGITAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2014
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: SAVI BREAST APPLICATOR; NUCLETRON ONCENTRA BRACHY
• Patient Outcome(s): Other