MAUDE Adverse Event Report: ATOS MEDICAL AB PROVOX BRUSH; AIRWAY DEVICE CLEANING BRUSH, INVASIVE

Catalog Number	7204
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: inspection was done visually in microscope.Internal investigation: the wire of the brush is broken.As seen in pictures in the investigation file, the bristles of the device are heavily worn.The bristles are destroyed and lying down, the bristles have not been suitable to perform their function for some time.Both the twisted steel wires are broken, almost at the same place.No deformations or clamp marks that could have caused the breakage was found.This indicates that the breakage is not due to any failure in the wire material since the twisted wire is made of stainless steel and unlikely to be broken at same place.However, it is possible to break the wire if the brush head is bent back and forwards a couple of times.There are also signs of wear seen in the shaft of the brush, whitening in the material indicates that the rear end of the shaft has been bent.In the ifu for provox brush there is a warning picture showing that bending the brush head is not allowed.Conclusion: no material failure is found.The twisted metal wires of the brush have been broken off at same place and this can happened if the wire was bent several times.According to manual it not allowed to bend the brush on the metal wire.The breakage is most likely caused by wrong handling of the product.Corrective and preventive action: inform the patient to change the brush when it is worn and follow the ifu.Bending of the twisted wire is not allowed.If bending is necessary it has to be done on the blue shaft as described in the ifu.
Event or Problem Description
We have received a complaint from university hospital of (b)(6) regarding a broken provox brush.The patient who has been using this provox brush said that she had not bended the brush.The provox brush broke in the provox prosthesis but the patient took the broken part or the tip of the brush away with a forceps.The situation was scary and the patient was frightened of the situation.Everything went fine but the missing piece could have ended up in the lungs or esophagus.Additional info: the prosthesis used was provox vega 8mm.

• Brand Name: PROVOX BRUSH
• Common Device Name: AIRWAY DEVICE CLEANING BRUSH, INVASIVE
• Manufacturer (Section D): ATOS MEDICAL AB; kraftgatan 8; horby, SE-24 222; SW SE-24222
• MDR Report Key: 7058457
• Report Number: 8032044-2017-00013
• Device Sequence Number: 13742943
• Product Code: LRC
• UDI-Device Identifier: 07331791000775
• UDI-Public: 7331791000775
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/06/2017

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 7204
• Device Lot Number: 1510001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 11/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention