MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-09-20 for XPRESS ENT DILATION SYSTEM MSB&LLF UNK_INE manufactured by Entellus Medical, Inc..
[120965282]
At the time of this report, no further patient injury or negative health related outcomes have been reported. The device was discarded after the procedure and the lot number was not provide/unknown. Therefore, no investigation of the device was completed.
Patient Sequence No: 1, Text Type: N, H10
[120965283]
It was reported that a patient experienced uncontrollable bleeding. After the physician dilated bilateral frontal and left sphenoid sinuses, the patient experienced uncontrollable bleeding. The patient was transferred to a hospital where a catheter embolization procedure was completed. Post-embolization the patient had partial vision loss in left eye. Physician stated the vision loss is related to embolization, and not balloon dilation procedure. Patient was not on anticoagulants prior to procedure and had no known bleeding issues. Physician feels that patient had a dehiscence of sphenoid sinus/bone tissue prior to the balloon dilation procedure which was a contributing factor to bleeding during balloon dilation procedure. The patient was hospitalized for one (1) week and discharged home. No further patient injury or complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006345872-2018-00004 |
| MDR Report Key | 7896361 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-09-20 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-08-23 |
| Date Mfgr Received | 2018-08-27 |
| Date Added to Maude | 2018-09-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. KAREN PETERSON |
| Manufacturer Street | 3600 HOLLY LANE NORTH SUITE 40 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7634637066 |
| Manufacturer G1 | ENTELLUS MEDICAL, INC. |
| Manufacturer Street | 3600 HOLLY LANE NORTH SUITE 40 |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPRESS ENT DILATION SYSTEM |
| Generic Name | SINUS BALLOON DILATION SYSTEM |
| Product Code | LRC |
| Date Received | 2018-09-20 |
| Model Number | MSB&LLF |
| Catalog Number | UNK_INE |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTELLUS MEDICAL, INC. |
| Manufacturer Address | 3600 HOLLY LANE NORTH SUITE 40 PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-20 |