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

Catalog Number	7204
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This is the event description received from the initial reporter: patient has had the brushes since (b)(6) 2021, she used one of the brushes to clean her voice prosthesis and as she removed it from her stoma the wire part of the brush detached from the plastic arm of the brush.The patient said it was only this brush that it happened to but as advised she has been using the brush a little longer than the recommended time frame.Several follow-up questions were sent but unfortunately reaching the user is difficult.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.Maximum use 30 days.
Additional Manufacturer Narrative
This report includes a theoretical investigation since no product was returned to the manufacturer.It was reported that the user used the brush "a little longer than the recommended time frame", which means more than max 30 days, according to the ifu.Event description is interpreted that the brush head was detached during cleaning of the voice prosthesis.Unknown which voice prothesis that was used (part of follow-up questions that hs not been answered).Serious injury: no.Medical intervention: no.Residual effect: no.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.The most likely point of breakage is the actual twisted metal wire if the brush head has been 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 ((b)(4)).It takes in average 65 times to bend the steel wire 90 degrees back and forth before it breaks and fall off ((b)(4)).Bending of brush head is not allowed according to illustration in the ifu.Taking all those facts in consideration, it is highly likely that the brush was damaged prior to usage as it is not likely that the medical-grade steel wire will break during a standard cleaning procedure.The applied forces are just too small to damage steel.Conclusion/action: based on previous complaint experiences of broken brush heads, and the fact that the ifu has not been followed regarding device lifetime max 30 days, 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.

• Brand Name: PROVOX BRUSH
• Common Device Name: 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: 13635611
• Report Number: 8032044-2022-00003
• Device Sequence Number: 5201321
• Product Code: LRC
• UDI-Device Identifier: 07331791000775
• UDI-Public: 07331791000775
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/10/2026
• Device Catalogue Number: 7204
• Device Lot Number: 2103001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown