MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-02 for NUVENT EM SINUS DILATION SYSTEM 1830617FRT70 manufactured by Medtronic Xomed, Inc..
[116196845]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078837 |
| MDR Report Key | 7746515 |
| Date Received | 2018-08-02 |
| Date of Report | 2018-07-25 |
| Date of Event | 2018-07-13 |
| Date Added to Maude | 2018-08-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUVENT EM SINUS DILATION SYSTEM |
| Generic Name | FRONTAL BALLOON / BALLOON SEEKER-70 DEGREE |
| Product Code | LRC |
| Date Received | 2018-08-02 |
| Returned To Mfg | 2018-07-16 |
| Model Number | 1830617FRT70 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6745 SOUTHPOINT DR. N. JACKSONVILLE FL 32216 US 32216 |
| Brand Name | NUVENT EM SINUS DILATION SYSTEM |
| Generic Name | FRONTAL BALLOON / BALLOON SEEKER-70 DEGREE |
| Product Code | LRC |
| Date Received | 2018-08-02 |
| Model Number | 1830617FRT70 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6745 SOUTHPOINT DR. N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-02 |