MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX LARYTUBE 9/36; LARYNGECTOMY TUBE

Catalog Number 7606

Device Problems Break (1069); Entrapment of Device (1212); Material Puncture/Hole (1504)

Patient Problem Dyspnea (1816)

Event Date 03/11/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has been conducted without a returned product and is therefore solely based on questions/answers and internal review of records as well as accumulated technical experience from engineering team.Investigation: the larytube material is sensitive to tear force and if there is a small fracture.The complaint indicates that it is the "ear" of the tube, where the neckband is attached, that broke off.Historically we have seen "ears" that have been broken in one place adjacent to the punched hole.When breakage of an ear is reported we believe that a small crack in the silicone is the probable cause.According to our experience of complaint of provox larytubes we have never seen a complete "ear" of a provox larytube that has been parted from the rest of the tube that the complaint indicates.One photo was received showing a small piece in a jar.Based on the sent-in-picture it is very difficult to establish that it is a piece from a provox larytube.The only part similar to the provox larytube design is the oblong hole, slightly corresponding to the design of the punched "ear" of provox larytube.A comparison between the photo, showing a small piece in a jar, and a provox larytube has been made which can be summarized in below comments: larytube was broken in 3 places (must have been made momentary) which is highly unlikely according to our experience.Thickness is not at all similar to the larytube.Broken off "ear" of larytube along the whole side has never been seen and is unlikely since the larytube design is injection molded in one piece except the punched hole in the "ear".The round design and its continuation do not resemble the design of provox larytube it was reported that the tubeholder "dale 240 blue" was used with the provox larytube.The ifu explains that only original components should be used.Provox tubeholder is designed and verified keeping the larytube in place.How the dale 240 blue product is affecting the provox larytube is unknown.The investigation cannot describe why and how the piece fell off.It was reported that the larytube was inspected before insertion.Provox larytube is made of silicone which is sensitive to oily substances that can break the material.In this case no oily substances was used according to the complaint.A search for nonconformities related to all constituent components in ref: 7606 lot: 2010215 was made.The result was one nonconformity, no: 200016150, regarding the injection molded tube component (ref 10596 tracheal cannula 10,5 x 13,5, lot 20.341.17) marks and cuts were found, the action was 100% inspection and nonconforming components were sorted out.Conclusion: inspection of the sent-in-picture cannot confirm that the piece is from provox larytube.Despite long term market experience of provox larytube we have never seen a complete ear falling off a provox larytube.No change in raw material or design have been made (search from 2013).We want to emphasize the importance of following the procedure in the ifu.The ifu states that "always carefully inspect the provox larytube before each use (i.E.Before insertion), and ensure that it is undamaged and shows no signs of tears, cracks or crusts.If you detect any damage, do not use the product, and obtain a replacement.Caution: use only original components.Other accessories may cause product damage and/or malfunction.Without a product return, it is difficult to draw any conclusions about what may have caused that event.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: part of the larytube broke off and customer had to go to the emergency room to have it taken out.Additional questions sent and answered by user (via reporter): have other products/medicines been used together with the product? no.What happened just before the tube broke? we rinsed it with water.Which part of the tube was broken off? the little things that hold the band.Why did the user need to go to the emergency? my husband was having trouble breathing.Where was the broken part? the ent pulled it out so in the airway.In which way was the user helped in the emergency? ent removed a part of the tube.Which instruments/equipment was used? i do not know, because i was not in the room.How is the user feeling today? he is feeling better, but recovering from his chemo and radiation.Are you sure that the tube is not available for return? a product return would help us in the investigation.Yes.Are any pictures of the tube available? i sent all the pictures i had to (b)(6).Attached is the only picture that i was sent although you cannot see much.Is it the red-ish part seen here? [sent-in-picture] yes it had blood on it.Was the larytube visually inspected before insertion? yes.After removal - was it confirmed that a part of provox larytube "ear" was missing? yes the ent and i confirmed it was missing.Describe how the tube was cleaned on a daily basis including all tools and detergents used.Cleaned with cold water and sometimes a brush.[i asked what brush].The atos brush.How was the larytube kept when not in use? usually on a paper towel.He puts it by his bed when he is in the front room.Were any customizations done to the tube? no.Was any holder used when the product broke? yes.If so, which brand/ref/lot? dale 240 blue.If so, is the holder available for product return? no.Was any oil based substances used nearby the stoma/product during the whole (month) time the tube was used? no.Are any remains of the larytube available for return? no.How far down in the airways did the piece end up? not sure i was not in there when they pulled it out.How was the piece retrieved from the airways? they pulled it out.The part we see in the sent-in-picture - is that the part that was retrieved from the airway? yes.Interpreting the sent-in-picture - 3 breakages seem to have happened.Was any cutting of the tube/loose part done after retrieval? no.Can you specify which part of the larytube that we see in the sent-in-picture? the part where the holder connects.[i asked if there is a hole in the part she is describing].Yes.[i asked if there was a hole in the part when they pulled it from his airway.] yes.Intended use: provox larytube is a holder for devices in the provox hme system intended for vocal and pulmonary rehabilitation after total laryngectomy.For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing.The provox larytube is intended for single patient use.Description of the product: provox larytube is a tube made of medical grade silicone rubber.The purpose of the device is to create a comfortable and airtight fit between the provox larytube and the tracheostoma, and also to provide attachment for devices from the provox hme system.Shall be attached with a provox tubeholder or provox laryclips.

Event Description

This is the information that was received from the initial reporter: part of the larytube broke off and customer had to go to the emergency room to have it taken out.Additional questions sent and answered by user (via reporter): q.Have other products/medicines been used together with the product? a no.Q.What happened just before the tube broke? a we rinsed it with water.Q.Which part of the tube was broken off? a the little things that hold the band.Q.Why did the user need to go to the emergency? a my husband was having trouble breathing.Q.Where was the broken part? a the ent pulled it out so in the airway.Q.In which way was the user helped in the emergency? a.Ent removed a part of the tube.Q.Which instruments/equipment was used? a.I do not know, because i was not in the room.Q.How is the user feeling today? a.He is feeling better, but recovering from his chemo and radiation.Q.Are you sure that the tube is not available for return? a product return would help us in the investigation.A.Yes.Q.Are any pictures of the tube available? a.I sent all the pictures i had to natalie.Attached is the only picture that i was sent although you cannot see much.Q.Is it the red-ish part seen here? [sent-in-picture] a.Yes it had blood on it q.Was the larytube visually inspected before insertion? a.Yes.Q.After removal - was it confirmed that a part of provox larytube "ear" was missing? a.Yes the ent and i confirmed it was missing.Q.Describe how the tube was cleaned on a daily basis including all tools and detergents used.A.Cleaned with cold water and sometimes a brush.[i asked what brush].The atos brush.Q.How was the larytube kept when not in use? a.Usually on a paper towel.He puts it by his bed when he is in the front room.Q.Were any customizations done to the tube? a.No.Q.Was any holder used when the product broke? a.Yes.Q.If so, which brand/ref/lot? a.Dale 240 blue.Q.If so, is the holder available for product return? a.No.Q.Was any oil based substances used nearby the stoma/product during the whole (month) time the tube was used? a.No.Q.Are any remains of the larytube available for return? a.No.Q.How far down in the airways did the piece end up? a.Not sure i was not in there when they pulled it out.Q.How was the piece retrieved from the airways? a.They pulled it out.Q.The part we see in the sent-in-picture - is that the part that was retrieved from the airway? a.Yes.Q.Interpreting the sent-in-picture - 3 breakages seem to have happened.Was any cutting of the tube/loose part done after retrieval? a no.Q.Can you specify which part of the larytube that we see in the sent-in-picture? a the part where the holder connects.[i asked if there is a hole in the part she is describing].Yes [i asked if there was a hole in the part when they pulled it from his airway.] yes intended use: provox larytube is a holder for devices in the provox hme system intended for vocal and pulmonary rehabilitation after total laryngectomy.For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing.The provox larytube is intended for single patient use.Description of the product: provox larytube is a tube made of medical grade silicone rubber.The purpose of the device is to create a comfortable and airtight fit between the provox larytube and the tracheostoma, and also to provide attachment for devices from the provox hme system.Shall be attached with a provox tubeholder or provox laryclips.

Manufacturer Narrative

This is a follow-up report after we have performed further analysis of the information and photo that we have had access to regarding this event.Conclusion: interpreting the sent-in-photo we cannot confirm that the piece is from a provox larytube, but rather contradict that this is from a larytube, as a broken off part cannot have the shape found in the image.A comparison in design can be seen in attached photo "(b)(4)", with the following comments: arrow a + c - this suggests that the larytube was broken in 3 places which is highly unlikely in our experience.Arrow b - the thickness is not similar to the larytube arrow c - broken off "ear" of larytube along the whole side have never been seen and is highly unlikely since the larytube design is injection molded in one piece, except the punched hole in the ear.Arrow d - the round design and the continuation of the piece bears no resemblance to the design of provox larytube in our experience we have never seen a complete ear falling of a provox larytube, the ear is part of the structural integrity injection molded together with the larytube.For the ear to come off cleanly from the housing resulting in the shape showing in the image, it has to, at a minimum, be cut by a scalpel or a sharp scissors.The ear being cut is contradicted by the answers received from the user stating that the larytube was inspected prior to use.Without any product return, it is impossible to conclude what was retrieved from the patient's airways.Due to the above conclusion, this report is hereby terminated.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.

• Brand Name: PROVOX LARYTUBE 9/36
• Type of Device: LARYNGECTOMY TUBE
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, swe 24235 ; SW 24235
• MDR Report Key: 11672129
• MDR Text Key: 262415266
• Report Number: 2135136-2021-00001
• Device Sequence Number: 1
• Product Code: KAC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/15/2021,03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 7606
• Device Lot Number: 2010215
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2021
• Distributor Facility Aware Date: 03/11/2021
• Event Location: Home
• Date Report to Manufacturer: 03/11/2021
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention