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

Catalog Number 7204

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/24/2022

Event Type  malfunction  

Manufacturer Narrative

This report includs investigation results of the actual used device.Investigation: handle part (only) from the product was returned on 2022-02-15.The soft tpe part in the top is crooked, most likely due to wire bending.As a reference an un-used provox brush was bended 90 degrees back and forth to investigate how the tpe is affected.After 67 cycles the brush head was broken.The tpe part is seen crooked.This comparison strengthens the theory that the product has been used incorrectly by bending the wire.The soft tpe part was cut off.The wire breakage is seen in a position where the wire is in a bended position.The manual attached to this batch was edition 2019-08-05.On page 2 an illustration shows that bending brush head (wire) is not allowed.On page 21 it is described what the user must inspect before each use.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 pp plastic shaft or handle, and a pp-plastic tip on top of the brush head.A disconnect between the twisted metal and the shaft is very unlikely based on that the brush head (stainless steel wire) is injection molded into the handle, experience and historical complaints.The most likely point of breakage is the actual twisted metal brush head that has been seen to break if bent extensively back and forth.This stainless steel wire has its breaking point at 758 n/mm^2 on average, making it very resilient to mechanical forces.It takes repeated damage to the material (such as bending it back and forth repeatedly) to weaken an subsequently break the material.The maximum forces applied to the brush during a cleaning procedure are at 13.7n (source: pf057-07, max.Esophageal flange strength).The chances of dislocating the voice prosthesis while cleaning are high when applying more than 13.7n of force.Therefore, the customer would have dislocated his vp before applying enough force to damage the brush by normal usage only.Furthermore, the average force needed to pull the brush head out of the brush handle is average 193n (stdev 18) for provox brush ref 7204 (internal reference tr-20-109).Taking all those facts in consideration, it is highly likely that the brush was damaged prior to usage as it is highly unlikely that the medical-grade steel wire broke during a standard cleaning procedure.The applied forces are just too small to damage steel.Conclusion/action: information provided in the ifu has not been read and understood since the brush has not been inspected before use.The most likely scenario is that the brush head has been bent by the user.Note: due to confidentiality reasons, the patient's name is not entered as the initial reporter.Instead, the sales representative's name is used.

Event Description

This is the event description received from the initial reporter: "when cleaning the voice prosthesis, the brush broke off the handle.The patient was able to remove the brush from the voice prosthesis herself.I have asked to return the brush, but don't know if the customer is in a position to do so.It's an elderly patient.The patient is very shocked by this incident.Follow-up questions were sent by atos medical.Answers received date 2022-01-26: how long was the actual product (that broke) used? 4 weeks.How long has the user been using the provox brush products? (in general) she has been using the product for 22 years.How many days is each brush normally used? 1 month.How many times per day does the user normally use the brush? 2 times a day, except when having a cold.How does the user clean and dry the brush? brush is cleaned with lukewarm water.When the brushes weren't used, how/where was is stored? in a cloth, in a glass.Was the attached manual (included the illustrations) read and understood in full by the user before use of the product? she has been using for 22 years, i don't think she uses the manual.The actual brush (that broke) - was the brush head or blue handle bended by the user? i will ask the daughter and ask her to sent the product back to us.Was the actual brush (that broke) inspected before use right before this happened? no.Which voice prosthesis was used? (not stated in form) provox vega, size unknown, this is ordered by the hospital and they do not mention the name of the patient.Did the user experience problem cleaning the vp before it broke? no.Can it be described in more detail what happened just before and after the brush head fell off? the daughter from the patient is calling me soon and then i will ask her.What does the user think is the reason that the brush head broke? she has no idea.How is the user feeling today? she is feeling fine now.Description of the product: provox brush is a device intended for cleaning of provox voice prostheses in-situ.Cleaning is recommended twice a day and after each meal.The voice prosthesis is seated in a puncture in the wall between esophagus and trachea.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.

• 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: karolina nilsson ; kraftgatan 8; hörby, 24235 ; SW 24235
• MDR Report Key: 13542365
• MDR Text Key: 288999539
• Report Number: 8032044-2022-00002
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 07331791000775
• UDI-Public: 07331791000775
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 7204
• Device Lot Number: 2104004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Date Manufacturer Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2021
• 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
• Patient Outcome(s): Required Intervention