MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX XTRAFLANGE 20; SILICONE WASHER INTENDED TO REDUCE PERIPROSTHETIC LEAKAGE

Catalog Number	7226
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: the product was not returned in this complaint, an investigation of the product is therefore not possible.The discussion of this investigation is based on internal discussions, documents and the ifu of the product.Follow-up questions to clinical educator deanna cohen-markedian (atos medical us): was the prosthesis and xtraflange placed at the same time? it was placed at the same time of the prosthesis.What was the result of the x-ray? the x-ray didn't show anything how is the patients status today? i spoke to the clinician yesterday.He believes he coughed into the sink.The clinician confirmed he is doing okay and has not required additional medical intervention.Discussion: the complaint report states that a provox xtraflange 20fr might have been dislodged by coughing forcefully.The complaint report also notes that the tracheal flange of the placed voice prosthesis started to curl outwards due to the effects of biofilm.The curling might have allowed to xtraflange to slip off the waist of the vp.An xtraflange 20fr weighs ~0,1g when the safety strap is cut off after successful placement.If the xtraflange slipped off and fell down the trachea into the lungs, it would be coughed out rather easily as a cough can travel up to 80km/h.A light piece of silicone with a high surface area would bear little resistance to an air flow like a cough.This assumption is also backed by the clinician who treated the patient.Furthermore, the patient did not need further medical assistance (besides an x-ray that did not show any traces of the xtraflange) and remains asymptomatic after the incident.Conclusion and action: nothing in the discussion indicates a faulty or malfunctioning product.The fact that the vp and the xtraflange were placed at the same time indicated that the xtraflange was working as intended and was safely attached to the waist of the voice prosthesis until the prosthesis itself was curling because of biofilm.That allows the assumption that this is not a product fault but rather a vp that should have been replaced earlier.
Event or Problem Description
This is the information that was received from the initial reporter: clinician reported that patient was seen in clinic.Patient reports he coughed forcefully and believes xtraflange dislodged.Xtraflange was not located by patient.Clinician ordered chest x-ray, however, aware that xtraflange is not radiopaque.Patient asymptomatic.Prosthesis was noted to have biofilm on tracheal flange which caused flange to be slightly curved inward.Description of the product: provox xtraflange is a silicone washer intended to reduce periprosthetic leakage that is detected on patients using indwelling provox voice prostheses.Placement is performed by a medical doctor or a trained medical professional in accordance with local or national guidelines.

• Brand Name: PROVOX XTRAFLANGE 20
• Common Device Name: SILICONE WASHER INTENDED TO REDUCE PERIPROSTHETIC LEAKAGE
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8, p.o. box 183; hörby, 24222 ; SW 24222
• MDR Report Key: 9375024
• Report Number: 8032044-2019-00007
• Device Sequence Number: 14219782
• Product Code: EWL
• UDI-Device Identifier: 07331791006937
• UDI-Public: 7331791006937
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K092593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2019

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 Catalogue Number: 7226
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1