MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-01 for SINUS BALLOON manufactured by Entellus Medical.
[79153314]
Entellus just received approval for use of their sinus balloon for dilation of the eustachian tube via the "512 k" process. However, their balloon is fundamentally different than the product by j and j that was approved via the traditional pathway. The eustachian tube should never be cannulated with a rigid instrument to avoid injury to the carotid artery. The j and j product is designed to avoid entry into the bony eustachian tube and minimize the risk of carotid injury. The entellus product has no such safety mechanism and it's rigid design dramatically increases the risk of penetration of soft tissue. If entellus is allowed to continue to market their product for this use, it is only a matter of time until there is a fatal carotid injury from its use. Clearly the fda was misled about the similarities between the two devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070782 |
| MDR Report Key | 6686023 |
| Date Received | 2017-07-01 |
| Date of Report | 2017-07-01 |
| Date Added to Maude | 2017-07-05 |
| 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 | SINUS BALLOON |
| Generic Name | EUSTACHIAN TUBE BALLOON DILATION DEVICE |
| Product Code | PNZ |
| Date Received | 2017-07-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ENTELLUS MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-07-01 |