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

Catalog Number 7204

Device Problem Material Rupture (1546)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: no product was returned yet.Therefore, a preliminary product investigation is performed.The theoretical assessment is made based on the given complaint description, product-ifus and internal documents.The complaint report states that the brush head of a new (less than a day of use) provox brush (ref#: (b)(4), lot1912004) fell off and into the trachea of the patient, which was confirmed by the neighbor of the patient.Patient was at the emergency department to get the brush head extracted by performing a bronchoscopy, or similar.No additional medical intervention was needed.The patient states that she inspected the brush, specifically the brush head, before use as she had an issue with a loose brush head before.Discussion: the brush head of the provox brush consists of nylon filaments as bristles, twisted metal wire (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 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.Furthermore, the average force needed to pull the brush head out of the brush handle is 193n for provox brush (ref.#: (b)(4)).Taking all those facts in consideration, it is highly likely that the brush was damaged 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: since no product was returned yet, we were not able to safely determine the cause of the failure.Note: due to confidentiality reasons, the patient's name is not entered as the initial reporter.The importer of the medical device has the traceability to the patient.As a manufacturer, we have chosen to include the importer's representative as the initial reporter in this report.The importer's representative can be contacted to provide information on the event if follow-up is necessary.

Event Description

This is the information that was received from the initial reporter: patient reported that she took a new provox brush out of the bag on saturday night (b)(6) 2020.She said it was the last one out of the pack of 6-lot 1912004.She said it was the previous style of brush and she was very familiar with using this brush.She said she inspected the brush because she had previously had the brush tip be loose when she got them out of the bag.She said that she reported the loose wire tip a year and a half ago and that new brushes were sent to her.She stated that ever since that experience she always checks the new ones.She said she did not notice anything out of the norm with the new brush on saturday night when she used it to clean her voice prosthesis.She said when she went to clean her tep the next morning on (b)(6) 2020, around 9:45 am before church is when the event occurred.She said she put the brush into the tep, and when she pulled it out, she noticed the whole wire tip was missing.She had her neighbor look in her stoma, and she could see the wire tip in her trachea, but was unable to retrieve it.She went to (b)(6) hospital, but they recommended she go to uc for more specialized care.She reported some shortness of breath, and was very fearful.She said she was seen in the er at ucmc from 1pm-5pm.The er team said they would prefer to avoid doing a bronchoscopy.She reported they numbed her trach, had her hold her breath, and they were able to retrieve the wire top of the brush after a few attempts.No other medical intervention was required.She reported that she was able to get the wire tip back from the md, and has both parts of the brush to return for examination.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 including evaluation of actual suspected device.The complaint report states that the brush head of a new (less than a day of use) provox brush (ref7204, lot1912004) fell off and into the trachea of the patient, which was confirmed by the neighbor of the patient.Patient was at the emergency department to get the brush head extracted by performing a bronchoscopy, or similar.No additional medical intervention was needed.The patient states that she inspected the brush, specifically the brush head, before use as she had an issue with a loose brush head before.Investigation: both the handle and the brush head of provox brush have been returned to atos medical ab for investigation on 2020-11-23.There were no missing pieces.The handle of the brush shows deformations of the pp-plastic surrounding the area where the metal wire of the brush head meets the handle of provox brush.When comparing the breakage of the complaint product with a provox brush where the brush head has been cut off as a reference this strongly indicates that the head of the complaint product has been bent, which is prohibited as stated in the ifu provox brush.Additionally, it is only possible to seamlessly put the two broken pieces together in an angled position, further confirming the initial observation.The inspection of the metal wire under a microscope shows cracks that are clearly caused by mechanical stress.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 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 193n for provox brush (ref7204).Taking all those facts in consideration, it is highly likely that the brush was damaged prior to 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 product failure is caused by bending the brush head, which is prohibited according to the ifu provox brush.The design of provox brush was optimized and is now available for sale.The new provox brush has a second tpe-layer around the metal wire to further protect it from tempering and damages.The design change was not deemed a safety enhancement and did not warrant a product recall.Note: due to confidentiality reasons, the patient's name is not entered as the initial reporter.The importer of the medical device has the traceability to the patient.As a manufacturer, we have chosen to include the importer's representative as the initial reporter in this report.The importer's representative can be contacted to provide information on the event if follow-up is necessary.

Event Description

This is the information that was received from the initial reporter: patient reported that she took a new provox brush out of the bag on saturday night (b)(6) 2020 (she said it was the last one out of the pack of 6-lot 1912004).She said it was the previous style of brush and she was very familiar with using this brush.She said she inspected the brush because she had previously had the brush tip be loose when she got them out of the bag.She said that she reported the loose wire tip a year and a half ago and that new brushes were sent to her.She stated that ever since that experience she always checks the new ones.She said she did not notice anything out of the norm with the new brush on saturday night when she used it to clean her voice prosthesis.She said when she went to clean her tep the next morning (b)(6) 2020 around 9:45 am before church is when the event occurred.She said she put the brush into the tep and when she pulled it out she noticed the whole wire tip was missing.She had her neighbor look in her stoma and she could see the wire tip in her trachea but was unable to retrieve it.She went to st.Elizabeth's hospital but they recommended she go to (b)(6) for more specialized care.She reported some shortness of breath and was very fearful.She said she was seen in the er at (b)(6) from 1pm-5pm.The er team said they would prefer to avoid doing a brochoscopy.She reported they numbed her trach, had her hold her breath and they were able to retrieve the wire top of the brush after a few attempts.No other medical intervention was required.She reported that she was able to get the wire tip back from the md and has both parts of the brush to return for examination.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: 10828421
• MDR Text Key: 216864843
• Report Number: 8032044-2020-00005
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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: 1912004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention