MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX BRUSH; VOICE PROSTHESIS BRUSH

Catalog Number 7204

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Information from an article; "blocked voice prosthesis: a common complication reducing the prosthesis longevity" by rajshekar halkud et.Al.International journal of head and neck surgery, may-august 2014;5(2):66-71.Extract: "a (b)(6)-year-old male who had undergone wide field laryngectomy with primary tracheoesophageal puncture (tep) with voice prosthesis 18 months back complained of blocked voice prosthesis and peritubal leakage.The (broken) tip of the cleaning brush which hade blocked the opening was removed in the outpatients under topical anesthesia and the peritubal block.

Manufacturer Narrative

At inspection of the pictures in the article it looks like it is a brush head from a provox brush and the blue tip indicates that it is a brush in current design.It has been broken off at the metal wire.The pictures also shown that the fistula was placed angled near 90º from the stoma and this placement of the prosthesis probably led to that the patient bent the brush at the metal wire to easier brush into the prosthesis.According to ifu there is a warning picture showing that bending the brush head below the shaft is not allowed.Another picture shows how to bend the brush on the shaft.Same pictures have been included in ifu for many years in different versions and are also included in the current version 201304a.The pictures have been included in ifu since the current model of brushes with blue tip was introduced in january 2008.No material error of the wires was found in production records of brushes.Broken brush head as it shown in the pictures in the article happens if the brush was bent several times at the metal wire.There are warnings in the ifu to inspect the brush and also how the shaft have to be bent and warning picture of not bending the brush head at the wire after the shaft.It is therefore judged that the instruction of how to use provox brush was not followed.Conclusion is that there is no product fault and therefore the breakage has to be caused by wrong handling of the product.

• Brand Name: PROVOX BRUSH
• Type of Device: VOICE PROSTHESIS BRUSH
• Manufacturer (Section D): ATOS MEDICAL AB; po box 183; kraftgatan 8; horby, SE-2 42 2; SW SE-242 22
• Manufacturer (Section G): ATOS MEDICAL AB; po box 183; kraftgatan 8; 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: 4416013
• MDR Text Key: 17995531
• Report Number: 8032044-2015-00001
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/14/2015

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 Catalogue Number: 7204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/17/2014
• Initial Date FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1