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

Catalog Number 8425

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/21/2022

Event Type  malfunction  

Manufacturer Narrative

This report includs investigation results of the actual used device.Investigation.The brush bristles are heavily worn.(possible explanation: boiling brush to sterilize it, resulting in deformed bristles; needs additional confirmation outside this complaint).The actual device is compared to a simulated used brush equivalent to 1 year of brush in vp in dry condition (worst case), bristles almost not seen worn at all.The brush is investigated under a microscope.A shiny material is seen around the tpe sealing (superglue?).Inspection of broken brush confirmed that the brush had been bended.Putting the two surfaces parts together (after tpe removal) the brush is in a bent position.The shiny material (superglue?) is also seen on the wire.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.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: bending of brush head is verified through putting the two surfaces against each other.The bristles are heavily worn and should not have been used according to inspection direction in ifu.Some unknown material is also seen around the pp/tpe sealing and the wire brush, which suggest that the brush head has been tried to be superglued together.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: during cleaning, the brush came loose from the handle on (b)(6) 2022.He then pulled the brush out of the vp.Questions were asked by atos medical to better understand the event.How long has the user been ordering/using the provox brush product? patient has been using it since (b)(6) 2012.How many days is each brush normally used? 1 to 2 weeks.How many times per day does the user normally use the brush? 3 times a day.How does the user clean and dry the brush? brush is rinsed with water and placed in the cup to dry - brush head on top.When the brushes weren't used, how/where was is stored? in the mirror cabinet in the bathroom, in a cup.Was the attached manual (included the illustrations) read and understood in full by the user before use of the product? yes.The actual brush that broke - was the brush head (a) or blue handle (b) bended by the user? no, always applied straight.Was the actual brush inspected before use right before this happened? yes.Which voice prosthesis was used? (not stated in form).Provox vega xtraseal 6 mm.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? took the brush out of the cup, moistened it a little under the tap and inserted it into the vp, pulled it out again while turning it slightly.Brush head is then stuck in the vp.Was the user injured, frightened or experienced discomfort? (not checked in form) scared, then was afraid of the next cleaning.What does the user think is the reason that the brush head broke? it was probably not sealed in properly.How is the user feeling today? ok.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 LONG XL
• 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: 13482245
• MDR Text Key: 290681370
• Report Number: 8032044-2022-00001
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 07331791015595
• UDI-Public: 7331791015595
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 8425
• Device Lot Number: 2105007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2021
• 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