MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-17 for RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER RV02 manufactured by Acclarent.
[5726539]
Acclarent was informed of an event that occurred during a procedure in which a reliev a vortex 2 sinus irrigation catheter was used. During the primary maxillary antrostomy procedure, there was no difficulty reported in accessing or dilating the maxillary sinus. Following dilation of the sinus ostium, the surgeon was said to have used 5ccs of saline at low pressure to obtain a culture from the maxillary sinus, with no reported swelling. A higher pressure lavage was then performed to wash out the maxillary sinus. Sometime thereafter, the patient was noted to have post septal orbital swelling around the left eye. The surgeon performed a lateral canthotomy to relieve the swelling. The patient was sent by an ophthalmologist in the recovery room, and there were no vision changes reported. Patient follow up occurred the following week and showed the patient was doing well with no further sequelae reported.
Patient Sequence No: 1, Text Type: D, B5
[13235744]
The subject device referenced in this report was discarded by the user facility and was not available for evaluation. Manufacturing records associated with the subject device could not be reviewed because the lot number was not available. The physician reported having no difficulties in using the acclarent devices during the procedure. The surgeon reported that the swelling was related to the irrigation, not the balloon. The surgeon also commented that the swelling resulted from a pre-existing defect in the patient's orbit through which the saline irrigation fluid entered the orbital space. A supplemental report will be submitted if additional information is received, and acclarent will continue to monitor this phenomenon for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2015-00007 |
| MDR Report Key | 4710281 |
| Report Source | 05 |
| Date Received | 2015-04-17 |
| Date of Report | 2015-03-31 |
| Date of Event | 2015-03-30 |
| Date Mfgr Received | 2015-03-31 |
| Date Added to Maude | 2015-04-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | IZABEL NIELSON, SR. MGR. |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506874924 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER |
| Generic Name | IRRIGATION CATHETER |
| Product Code | KAR |
| Date Received | 2015-04-17 |
| Model Number | NA |
| Catalog Number | RV02 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-17 |