MAUDE Adverse Event Report: SINUSYS CORP VENT-O'S BILATERAL OSMOTIC DILATOR; MAXILLARY SINUS OSTIUM DILATOR

Model Number SNS-110

Device Problems Break (1069); Component Falling (1105); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Other  

Event Description

Dear sirs: i am a head and neck surgeon in (b)(6).I am writing to discuss with you a problem i encountered with a medical device which i feel is very serious.The device is used for sinus problems - it is a maxillary sinus ostium dilator, which is made by a company called sinusys corporation.I used their vent-o's bilateral osmotic dilator, (b)(4), lot no.13242-032514, with expiration date of 09/01/2014.I used this maxillary sinus osmotic dilator during an endoscopic sinus surgery case.The dilator was placed within the pt's maxillary sinus ostium and after approx 40-45 minutes of dilation time, when i attempted to remove the maxillary sinus ostium dilator, the suture attachment to the dilator snapped and broke during its extraction and thus, the sinus dilator plastic foreign material fell into the pt's maxillary sinus.Fortunately, i was able to retrieve this piece of plastic equipment prior to it migrating further into the pt's sinus or down into their airway.However, i was very concerned regarding this important safety issue.I immediately discussed with a company rep, (b)(4), who is the territory manager for (b)(6) for the sinusys corporation, the need to send this product back to the company for further eval and also to file an fda report.I consider it very dangerous that the sinus device has suture fixations which are not stable and can snap off of the device with minimal force.I was assured by the company rep that the suture attachment would not break free from the device despite pulling strongly on them; nonetheless, this was not true.I would just like to inform you of this important equipment malfunction as i feel that it is a danger to future pt use.If the sinus dilator breaks free and is no longer secured by a suture, it can easily be aspirated, inhaled, or lodged in a location where it would present a foreign body risk and hazard.I contacted (b)(4), who assured me that appropriate steps were being taken to investigate this device malfunction.I have not heard from the company in regard to their eval, so i am following up on my own in order to advise you of this significant safety risk to future pt use.This product needs a thorough eval, and i would not recommend using it again until it has been modified to ensure safety with use.Please don't hesitate to contact me with any questions.(b)(6).

• Brand Name: VENT-O'S BILATERAL OSMOTIC DILATOR
• Type of Device: MAXILLARY SINUS OSTIUM DILATOR
• Manufacturer (Section D): SINUSYS CORP
• MDR Report Key: 4192840
• MDR Text Key: 15999766
• Report Number: MW5038701
• Device Sequence Number: 1
• Product Code: LRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/01/2014
• Device Model Number: SNS-110
• Device Lot Number: 13242-032514
• Patient Sequence Number: 1