MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX BRUSH; AIRWAY DEVICE CLEANING BRUSH, INVASIVE

Model Number 7204

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Aspiration/Inhalation (1725)

Event Type  Injury  

Manufacturer Narrative

A theoretical investigation was performed, samples were not available.The brush had not been used for a month.The brush was cleaned with water and was not bent.Did not appear broken before use.The brush head entered the trachea.The brush was used to clear mucus inside the stoma.Discussion: the brush head of the provox brush consists of nylon filaments as bristles, twisted metal wire (diameter: 0.65mm, stainless steel) that is injection molded inside a polypropylene (pp) plastic shaft or handle, and a pp-plastic tip on top of the brush head.The average force needed to pull the brush head out of the brush handle is 193n for provox brush (ref(b)(4)).The brush head will not snap unless excessive force or repeated bending break it off.According to the ifu it should never be bent in the wire, only the brush shaft should be bent.Cleaning of the stoma is not an intended use of the brush.It is stated in the ifu that it should be used for cleaning of the prosthesis or used as a help to attach a plug or lubricant.Conclusion: product error cannot be concluded, sample could not be returned for investigation.The user has not followed given instructions in the ifu regarding intended use (cleaning of stoma is not an intended use).The brush head has disconnected from the shaft before.It is assessed that the cause is user error.Inform the user to read and follow the ifu, only use the brush for what it is intended, not to bend the brush head and inspect the brush before each use.Cause code will be user error.The manufacturer will be informed.Corrective action/preventive action: vigilance trend data do not show any unacceptable trends.No corrective action/preventive action is considered necessary at this stage of the investigation.

Event Description

The brush head came away from the handle and when down the patient's throat which resulted in a 9 hour stay at the hospital for the patient.Follow-up questions were sent to retrieve more information about the event and the following information was gathered: the brush had been used a few times before and had not been used for longer than a month (maximal usage time).The brush did not appear damaged before use and had only been cleaned with warm water.The patient had not been using the brush to clean the voice prosthesis, but to clear mucus around the inside of the stoma.When doing so the part of the brush with metal wire and bristles ("brush head") detached from the moulded plastic handle and fell down into the patient's trachea.The brush head could be retrieved by hospital personnel without any issues since it had not gone down very far into the patient's trachea.The patient's attitude to use the brush is now not as positive as before the incident.Description of the product: the provox brush is a device helping to clean provox voice prostheses or fenestration holes in larytube or can be used for application of flourosilicone oil or anti-candida medication into provox voice prostheses.The distal end of the brush can help to place provox plug and provox vega plug into the voice prosthesis.The brush is intended for single patient re-use and is intended for both home and clinical use by patient or clinician.Maximal use 30 days.Intended use: provox brush is a single patient use device intended for cleaning provox voice prostheses, for insertion of provox plug and provox vega plug, for applying lubricant and anti-candida agents and for cleaning of fenestration holes on provox larytubes.The product is intended for use by the patient.

• Brand Name: PROVOX BRUSH
• Type of Device: AIRWAY DEVICE CLEANING BRUSH, INVASIVE
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; hörby, 24235 ; SW 24235
• Manufacturer (Section G): ATOS MEDICAL AB; kraftgatan 8; hörby, 24235 ; SW 24235
• Manufacturer Contact: sofia thomasson ; kraftgatan 8; horby, SE-24-235 ; SW SE-24235
• MDR Report Key: 18889075
• MDR Text Key: 337481511
• Report Number: 8032044-2024-00002
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 07331791000775
• UDI-Public: 07331791000775
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 7204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention