MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX ACTIVALVE STRONG 4.5 MM; INDWELLING VOICE PROSTHESIS

Model Number	Strong
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includs a theoretical investigation since no product was returned to the manufacturer.This report will be based on information given by the customer.According to the information given in the complaint form, provox xtraflange was used together with the device.Follow-up questions from atos medical are sent but not yet answered.Serious injury: no.Residual effect: no.Two different scenarios are possible due to the complaint report, either that the event happened when the older prosthesis was removed or when the new one was inserted.Old prosthesis: too much force used during cleaning the prosthesis may have harmed the prosthesis.The voice prothesis shall only be cleaned according to the ifu using provox brush, in combination with the provox flush if preferred.Sharp tools shall never be used.Provox brush shall be used with twisting movements meanwhile pushing it in and out of the prosthesis, according to the ifu.It is not possible to predict the life time in-situ of provox activalve.Over time, the prosthesis will be affected by bacteria and yeast that will cause the silicone to deteriorate.Overdoing cleaning (excess force and/or sharp instruments) will contribute to shorten the lifetime of the device.Provox xtraflange was attached after insertion.This supports the thought that this complaint concerns an old, used prosthesis.New prosthesis: adding too much force during insertion can damage the valve and causing the flap to be torn off.Therefore it is important to fold the flanges according to the ifu and never use any sharp instruments or excessive force.The silicone in the flap's hinge is flexible and strong but may rip if damaged.Prostheses manufactured at atos medical, are 100% visually inspected at several of the manufacturing steps.Leakage- and pressure drop tests are also performed.Therefore, it is not likely that a faulty prosthesis was delivered.Conclusion: root cause cannot be unambiguously determined as some facts are missing.If the prosthesis was old, the failure mode could be caused by wear and tear, possibly in combination with excessive force during cleaning.If the prosthesis is new, it could be that excessive force was used during insertion.Cause code will be user error, as it is more likely that the prosthesis was old and that the flap got loose while taking the prosthesis out of the puncture, due to the fact that an xtraflange was attached.Most probable it is solely the result of a use error with no other performance issue, but since information is missing, we prefer to report this as-is to err on the side of caution.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 or Problem Description
This is the event description received from the initial reporter: the doctor was changing the prosthesis when a piece fell off into the pts airway.The dr.Was able to suction it out.Pt's wife was contacted and brought the reserve prosthesis from home.The backup tep was then changed with no problems.The dr.Was upset as she claims she has never experienced this before in her many years of dealing with tep changes and the laryngectomy population.Ref 7275 provox xtraflange 22.5 was used together with the product.Several follow-up questions have been sent and also requests for the complaind product but unfortunately no response has been recieved by the manufacturer.Description of the product: provox activalve is an unsterile indwelling voice prosthesis intended for anterograde insertion in a healed puncture for voice rehabilitation after total laryngectomy.The device is intended for patients who are experiencing early leakage with previous voice prostheses (device life less than 4-8 weeks).The device reduces the need for frequent replacements in a majority of users, but not in all.The voice prosthesis is seated in a puncture in the wall between esophagus and trachea.

• Brand Name: PROVOX ACTIVALVE STRONG 4.5 MM
• Common Device Name: INDWELLING VOICE PROSTHESIS
• 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: 13802853
• Report Number: 8032044-2022-00004
• Device Sequence Number: 5008528
• Product Code: EWL
• UDI-Device Identifier: 07331791000577
• UDI-Public: 07331791000577
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K092593
• 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): 03/03/2022

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: Health Professional
• Device Model Number: Strong
• Device Catalogue Number: 7160
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown