MAUDE Adverse Event Report: MEDTRONIC XOMED, INC. NUVENT EM SINUS DILATION SYSTEM; FRONTAL BALLOON / BALLOON SEEKER-70 DEGREE

Model Number 1830617FRT70

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 07/13/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, at 1200-hours, the surgeon was performing a balloon sinuplasty procedure using the frontal balloon (balloon seeker) em 70-degree with the inflator kit on a pt.Once the balloon was inserted, the balloon was inflated, but while being inflated, the balloon popped.After the balloon popped, the device was removed.Shortly after being removed, the balloon insufflation device was re-filled with h2o and inserted back into the pt's nose.The surgical team attempted to re-inflate the balloon, but they discovered that the balloon was leaking so it was removed from the pt and a new frontal balloon was retrieved, opened at the surgical area and filled with h2o.The new balloon was inserted into the pt, the surgical team attempted to inflate the balloon, but to no avail.During this attempt to inflate the balloon, the surgeon said that there was air in the tubing.So, the balloon was once again removed from the pt and filled with h2o; the balloon was re-inserted into the pt and inflated.This time the surgeon noticed bubbles (csf leak) in the sinus.At this time, the surgeon stated that he was going to have to perform a septum repair before he could fix the leak.Finally, after the surgery, the first frontal balloon was removed from the surgical area, placed in its original box and returned to the manufacturer."is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: yes.".

• Brand Name: NUVENT EM SINUS DILATION SYSTEM
• Type of Device: FRONTAL BALLOON / BALLOON SEEKER-70 DEGREE
• Manufacturer (Section D): MEDTRONIC XOMED, INC. ; 6745 southpoint dr. n.; jacksonville FL 32216
• MDR Report Key: 7746515
• MDR Text Key: 116196845
• Report Number: MW5078837
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1830617FRT70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR