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 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Product has not been returned, hence this is a theoretical investigation based on complaint description, follow-up questions, product-ifus and internal documents as well as accumulated technical experience from previous complaint investigations.Event description explains that the tip of the provox brush broke and almost fell into his windpipe, stuck to tunica mucosa tracheae and did not fall deep inside the bronchus.It was removed by a doctor with forceps at the emergency room.No residues could be found.Patient left the hospital.The event happened in (b)(6) on 2021.According to complaint report it is unknown how long time the actual product has been used, also unknown if the brush has been used according to instruction.According to atos medical japan inc.: the hospital has not been received any further information about health issue arose from the patient.The local office are currently waiting for the product to returned, or photos of the product and the health status of the user.-the voice prosthesis, which provox brush was co-packed with, was replacement (b)(6) 2021.There is no information when the brush was first used, but it has been available at the customer 2021-04-23 to 2021-09-01 = over 4 months (the product shall not be used for more than 30 days according to the ifu).Investigation: the complained product, provox brush, is included in the sales box for provox vega voice prosthesis.According to atos medical japan inc.The lot number of provox vega is most likely 2101083 or 2012047.Both of these lots includes provox brush (1 pc) of lot 20.421.07.This lot is produced according to (b)(4) ed 21 which is the 2020 design with shorter shaft and soft tpe sealing.Discussion: the brush head of 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: (b)(4), 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 (b)(4) (internal reference (b)(4)).Taking all those facts in consideration, it is highly likely that the brush was damaged prior to usage as it is unlikely that the medical-grade steel wire broke during a standard cleaning procedure.The applied forces are just too small to damage steel.Conclusion: since no product return is available and we are missing information, we are not able to definitely determine the cause of the failure.The most likely root cause is the brush head has been bent several times back and forth.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: that patient had the incident that the tip of provox brush broke and almost fell into his windpipe but it stuck to tunica mucosa tracheae so it did not fall deep inside the bronchus.(this happed at night) he went to an emergency room and a doctor took the brush tip out with a forceps.The doctor took a look at inside his bifurcation of trachea very carefully by using microscope but any foreign matters were found inside, so he left the hospital without having other treatments.The fallen brush tip is currently kept at the hospital.Atos requested the hospital taking pictures of the brush tip and send them to atos sales rep.We are currently confirming if the patient has any further health issues caused by this incident.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.

Event Description

This is the event description received from the initial reporter: that patient had the incident that the tip of provox brush broke and almost fell into his windpipe but it stuck to tunica mucosa tracheae so it did not fall deep inside the bronchus.(this happed at night) he went to an emergency room and a doctor took the brush tip out with a forceps.The doctor took a look at inside his bifurcation of trachea very carefully by using microscope but any foreign matters were found inside, so he left the hospital without having other treatments.The fallen brush tip is currently kept at the hospital.Atos requested the hospital taking pictures of the brush tip and send them to atos sales rep.We are currently confirming if the patient has any further health issues caused by this incident.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.

Manufacturer Narrative

This is a follow-up report after the device has been returned to the manufacturer and been evaluated.Atos medical has also received additional information from the initial reporter.Answers to questions received 2021-10-05: q how long has the brush been used? a unknown.Q how often (times per day) was the brush used during this period? a more than 3 times a day (after each meal).Q when the brush was not in use, how/where was is kept? (in pockets/plastic bag/in a box etc)? a unknown.Q was the brush bended anytime during this usage? if yes, where? a no q was the ifu read and understood in full? a unknown.Q was the brush inspected before use right before this happened? a unknown.Q how is the user feeling today? a the patient has no further health issue.The initial reporter are no longer sure if the given lot number of the brush is the correct one.Investigation: the brush head and handle was disinfected in 70% ethanol for 24 hours prior to handling.It is confirmed that the provox brush design is of the latest design with short handle and tpe sealing.-the brush bristles are deformed and should not have been used.Bristles seem melted, probably due to high temperature such as boiling in water which is not allowed.-the brush wire has been bended which is prohibited and not in accordance with the ifu.This is the reason why the brush head was broken.-the product has been used in contradiction to the included ifu, in the section "before use" it is stated before each use, make sure that: · the bristles do not appear worn or are loose.· the wires are not bent or broken.The ifu picture illustration "1" also clearly explain visual inspection of the bristles.It was reported "unknown" if the user had understood the ifu and inspected the brush before use.Beyond this complementary investigation the original investigation is still valid with regards of the section discussion below.Conclusion: bending of the brush head caused the wire to break.The brush was used with heavily worn/deformed bristles.Both of the above indicate clear misuse of the product and not in accordance with the ifu.No product malfunction can be established.Discussion: the brush head of 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 unlikely that the medical-grade steel wire broke during a standard cleaning procedure.The applied forces are just too small to damage steel.Note: due to confidentiality reasons, the patient's name is not entered as the initial reporter.Instead, the sales representative's name is used.

• Brand Name: PROVOX BRUSH
• Type of Device: AIRWAY DEVICE CLEANING BRUSH, INVASIVE
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; hörby, 24235 ; SW 24235
• MDR Report Key: 12518731
• MDR Text Key: 272906207
• Report Number: 8032044-2021-00007
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• 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: 20.421.07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1