MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX XTRAFLANGE 22.5; SILICONE WASHER INTENDED TO REDUCE PERIPROSTHETIC LEAKAGE

Catalog Number	7275
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: no product will be returned according to the reporter.Therefore, atos medical ab have sent further questions to the reporter to be able to perform a theoretical investigation of the root cause of the event.Information and conclusion from the investigation will be summarized in a follow up report.Exemption number e2018017.Atos medical ab (manufacturer) is submitting the report on behalf of (b)(4) (importer).Contact person for the importer is provided in f3-5.Address of the importer is, (b)(4), usa atos medical ab, manufacturer, registration no.3002806269.(b)(4), importer, registration no.3007501574.
Event or Problem Description
This is the information that was received from the initial reporter: provox xtra flange 22.5fr was placed on (b)(6) 2019 in clinic, while on zoom with a clinical rep from atos.When the patient woke up on (b)(6), the xtra flange had dislodged.He contacted his clinician around 9am, stating he was cleaning his prosthesis and started coughing.He noticed that there was a "white piece" in his airway which he then was able to remove with his blue brush.Patient denies manipulating the xtra flange; however, he did note a very tight fit of his larytube when placing the previous night.Description of the product: provox xtra flange 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.
Event or Problem Description
This is the information that was received from the initial reporter: provox xtra flange 22.5fr was placed on (b)(6) 2019 in clinic, while on zoom with a clinical rep from atos.When the patient woke up on 5/10, the xtra flange had dislodged.He contacted his clinician around 9am, stating he was cleaning his prosthesis and started coughing.He noticed that there was a "white piece" in his airway which he then was able to remove with his blue brush.Patient denies manipulating the xtra flange; however, he did note a very tight fit of his larytube when placing the previous night.Description of the product: provox xtra flange 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.
Additional Manufacturer Narrative
Investigation: this is a follow up report (#1).No product has been returned to the manufacturer, therefore this is a theoretical evaluation of the root cause of the event.We have also asked questions to people involved in placing the device to better substantiate the theoretical evaluation.Theoretical evaluation: without having access to the actual product it is difficult to do a proper investigation.However, an atos representative, who is very experienced, where present on zoom when placing xtra flange and we can therefore with high probability exclude that the xtra flange was damaged during placement.A check that the product was correctly positioned was done by the clinician before the patient left the health care facility.The most likely cause for this to happen is that the patient may accidentally have pulled off/damaged the xtra flange when inserting the larytube.The user himself noticed "a very tight fit of his larytube when placing" hence a contributing cause may also be that a wrong size of larytube was used.It is stated in the ifu of the product; precautions instruct the patient to be careful when cleaning the voice prosthesis and stoma, and when inserting devices such as larytubes and larybuttons into the stoma.Provox xtra flange may be accidently removed and aspirated.If this occurs the patient must seek immediate medical attention.Conclusion: nothing in the theoretical evaluation indicates a faulty or malfunctioning product.Exemption number e2018017.Atos medical ab (manufacturer) is submitting the report on behalf of atos medical, inc.(importer).Contact person for the importer is provided.Address of the importer is, (b)(6).Atos medical ab, manufacturer, registration no.(b)(4).Atos medical, inc., importer, registration no.(b)(4).

• Brand Name: PROVOX XTRAFLANGE 22.5
• 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: 8669649
• Report Number: 8032044-2019-00003
• Device Sequence Number: 16731709
• Product Code: EWL
• UDI-Device Identifier: 07331791006920
• UDI-Public: 7331791006920
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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 Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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 Expiration Date: 10/28/2023
• Device Catalogue Number: 7275
• Device Lot Number: 1811199
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/10/2019
• Device Age: 6 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1