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

Catalog Number 7204

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: no product was returned.Therefore, a product investigation could not be performed.A theoretical assessment is made based on the given complaint description, product-ifus and internal documents.The complaint report and the user feedback states that the brush head of a provox brush broke off during the usual cleaning routine without any indication of damages beforehand.According to the customer, the brush head was bent by inserting it into a cannula and by cleaning the voice prosthesis ("insertion into trachea").Furthermore she states that the brush was visually inspected before using as stated in the ifu - apparently, no damages were visible.The brush head of the provox brush consists of nylon filaments as bristles, twisted metal wire (name: sus304, diameter: 0.65mm, stainless steel) and a pp-plastic tip on top of the brush head.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, compare complaint #200012852) to weaken an subsequently break the material.Furthermore, sus304 is a medical grade steel used in a variety of medical products (such as implants and surgical tools).As a consequence, this kind of steel has to pass vigorous quality controls.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.Taking all those facts in consideration, it is highly likely that the brush was damaged by bending before usage as it is physically impossible that the medical-grade steel wire broke during a standard cleaning procedure.The applied forces are just too small to damage steel.Conclusion: the damage to the product is most likely caused by wrong handling of the product.Bending of the twisted wire is not allowed.If bending is necessary it has to be done on the blue shaft as described in the ifu.A new design of provox brush will be implemented in q1 2020.This change will bring an updated brush that includes a tep-sealing in between the pp-handle and the brush head.The purpose of this seal is to prevent brush heads from breaking off by bending.

Event Description

This is the information that was received from the initial reporter: the patient reports that the brush head of the provox brush ref 7204 broke off and fell into her windpipe, which she took out independently.Additional questions was asked to the patient via a sales rep.When exactly did the incident happen? before christmas, the patient couldn't give me an exact date.Did the incident affect your health (breathing problems, bleeding,.)? no, she had no health problems.Could you describe the course of the incident again in detail? she used the brush as always, but the brush was used for a period of 4-5 weeks with daily use (the change is planned every 2 weeks), it not only cleans the cannula but also goes with the brush into it trachea to remove mucus or secretions.She herself does not bend on the brush, she said that the brush is bent due to cleaning and bends on the wire.When she found that the brush head was no longer there and she had a strange feeling in the windpipe, she took the bark tweezers and removed the foreign body in a short time.Did the user read the manual before use? no, because the patient has been using the brushes for 16 years and has never had any problems.Did you bend the brush? if yes, where? according to the patient, she did not bend the brush, the brush bent itself when inserted into the cannula and trachea.Have you checked the brush visually before using it? yes, but nothing was visible.Description of the product: provox brush is a device intended for cleaning of provox voice prosthesis in-situ.Cleaning is recommended twice a day and after each meal.

Manufacturer Narrative

This is a follow-up report / final report: atos medical ab has received the message that no product will be returned for investigation.The theoretical investigation based on internal documents, similar complaints and discussions remains valid.The investigation of this complaint is hereby closed without any additional information.Investigation: no product was returned.Therefore, a product investigation could not be performed.A theoretical assessment is made based on the given complaint description, product-ifus and internal documents.The complaint report and the user feedback states that the brush head of a provox brush broke off during the usual cleaning routine without any indication of damages beforehand.According to the customer, the brush head was bent by inserting it into a cannula and by cleaning the voice prosthesis ("insertion into trachea").Furthermore she states that the brush was visually inspected before using as stated in the ifu - apparently, no damages were visible.The brush head of the provox brush consists of nylon filaments as bristles, twisted metal wire (name: sus304, diameter: 0.65mm, stainless steel) and a pp-plastic tip on top of the brush head.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, compare complaint #200012852) to weaken an subsequently break the material.Furthermore, sus304 is a medical grade steel used in a variety of medical products (such as implants and surgical tools).As a consequence, this kind of steel has to pass vigorous quality controls.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.Taking all those facts in consideration, it is highly likely that the brush was damaged by bending before usage as it is physically impossible that the medical-grade steel wire broke during a standard cleaning procedure.The applied forces are just too small to damage steel.Conclusion: the damage to the product is most likely caused by wrong handling of the product.Bending of the twisted wire is not allowed.If bending is necessary it has to be done on the blue shaft as described in the ifu.A new design of provox brush will be implemented in q1 2020.This change will bring an updated brush that includes a tep-sealing in between the pp-handle and the brush head.The purpose of this seal is to prevent brush heads from breaking off by bending.

Event Description

This is the information that was received from the initial reporter: the patient reports that the brush head of the provox brush ref 7204 broke off and fell into her windpipe, which she took out independently.Additional questions was asked to the patient via a sales rep.When exactly did the incident happen? before christmas, the patient couldn't give me an exact date.Did the incident affect your health (breathing problems, bleeding,.)? no, she had no health problems.Could you describe the course of the incident again in detail? she used the brush as always, but the brush was used for a period of 4-5 weeks with daily use (the change is planned every 2 weeks), it not only cleans the cannula but also goes with the brush into it trachea to remove mucus or secretions.She herself does not bend on the brush, she said that the brush is bent due to cleaning and bends on the wire.When she found that the brush head was no longer there and she had a strange feeling in the windpipe, she took the bark tweezers and removed the foreign body in a short time.Did the user read the manual before use? no, because the patient has been using the brushes for 16 years and has never had any problems did you bend the brush? if yes, where? according to the patient, she did not bend the brush, the brush bent itself when inserted into the cannula and trachea have you checked the brush visually before using it? yes, but nothing was visible.Description of the product: provox brush is a device intended for cleaning of provox voice prosthesis in-situ.Cleaning is recommended twice a day and after each meal.

• Brand Name: PROVOX BRUSH
• Type of Device: AIRWAY DEVICE CLEANING BRUSH, INVASIVE
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8, p.o. box 183; hörby, 24222 ; SW 24222
• MDR Report Key: 9676015
• MDR Text Key: 220750166
• Report Number: 8032044-2020-00001
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 07331791000775
• UDI-Public: 7331791000775
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• 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: 1907001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1