MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX LARYBUTTON; TRACHEOSTOMY BUTTON

Model Number 18/8

Device Problems Use of Device Problem (1670); Inadequate User Interface (2958)

Patient Problems Aspiration/Inhalation (1725); Respiratory Distress (2045)

Event Date 12/09/2013

Event Type  Injury  

Event Description

This incident was reported to us (b)(4) 2014.Slp reported: it happened (b)(6) 2013, changed filter, aspirated the larybutton freaked out and tried to grab it and pushed it further.The wife tried to help with tweezers and pulled out prosthesis.On (b)(6), a redtube catheter was placed; on (b)(6) a new prosthesis was placed.They then performed a bronchotomy and retrieved the larybutton, removed in total.Patient was informed not to wear a larybutton without a tubeholder from here on out.Slp went over all the educational information again with the patient and his wife.Additional/ corrected information from our sales rep - (b)(4) who went and spoke with the slp in person (b)(4) 2014.1.The patient didn't go into the or until the middle of the night.This is part of the reason that the days went from one to the next.Once he got to the hospital, they decided to wait until the next day to remove the larybutton.It wasn't causing immediate breathing difficulty.2.According to the patient's report and the slp today, the patient had folded the larybutton in half to make it easier to insert.This is common for those that use the button.When he went to insert it, he coughed and then breathed the larybutton in at the same time.He then made it go into his stoma and out of reach for himself with further attempts to remove it.This is when he went to the hospital.3.There were no modifications to the larybutton.4.He was not wearing laryclips or a tubeholder as the original fitting was such that it was a tight fit.Thus the need to fold it to place it in the stoma.5.The slp told me today, that the patient is not compliant with what she has told him and recommended as he was wearing the larybutton last visit without the tubeholder or laryclips and she distinctly told him he was not allowed to wear it without one of those two options.The patient has been intermittently compliant with the things that have been recommended for his safety and best use of products.

Manufacturer Narrative

Investigation: no product has been returned and can therefore not be investigated.Conclusion/action: based on the descriptions, the patient has used the larybutton without securing it with provox tubeholder or provox laryclip even if the slp has determined that there is a need for this.In the ifu it is described how to fold the device and several warnings and precautions regarding the issue.See extractions from instructions for use below.The patient has clearly not been following the slp´s advice on how to use the device, nor the instructions and warnings in the ifu.Additionally the device is a prescription device and, as stated in the ifu, it must always be evaluated if the larybutton is a suitable device for the patient.This should also be reevaluated; potential users of the provox larybutton must have sufficient cognitive ability, manual dexterity, and visual acuity to understand and follow the instructions for use.If you doubt in any way that your patient fulfills all of the above criteria, including that he or she has fully understood the information you have provided, do not prescribe the provox larybutton.Excerpt from the ifu clearly outlining the risks and how to safely insert and use the device: - if the product is pushed too far into trachea it may obstruct breathing.Always insert the larybutton according to the instructions in this ifu.Insert and remove the provox larybutton with caution insert or remove devices that you keep in the provox larybutton carefully while using one hand to keep the provox larybutton in place.Insertion: fold the tracheal end with your fingers as seen in figure 3, and hold it firmly folded.Insert the tracheal end into your tracheostoma and release the tracheal end (figures 4 and 5).Gently insert the provox hme system component that you intend to use.Potential users of the provox larybutton must have sufficient cognitive ability, manual dexterity, and visual acuity to understand and follow both the instructions for use *if you doubt in any way that your patient fulfills all of the above criteria, including that he or she has fully understood the information you have provided, do not prescribe the provox larybutton.Corrective action: advice the slp to evaluate if the larybutton really is a suitable product for this patient.Inform the patient about the importance of reading and follow the instructions for use.Device not returned.

• Brand Name: PROVOX LARYBUTTON
• Type of Device: TRACHEOSTOMY BUTTON
• Manufacturer (Section D): ATOS MEDICAL AB; po box 183; horby, SE-2 42 2; SW SE-242 22
• Manufacturer (Section G): ATOS MEDICAL AB; po box 183; horby, SE-2 42 2; SW SE-242 22
• Manufacturer Contact: ferenc dahner ; po-box 183; horby, SE-24-2 22 ; SW SE-242 22 ; 415 19800
• MDR Report Key: 3687862
• MDR Text Key: 4298104
• Report Number: 8032044-2014-00002
• Device Sequence Number: 1
• Product Code: KAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2017
• Device Model Number: 18/8
• Device Catalogue Number: 7674
• Device Lot Number: 1210122
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2014
• Initial Date FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2012
• 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