MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-03 for RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER RV02 manufactured by Acclarent, Inc..
[4225232]
Acclarent was notified on (b)(6) 2014, of a domestic event that occurred during a sinus surgical case when acclarent balloon dilation technology was used. The patient had experienced right eye swelling during a balloon sinuplasty procedure. This was the first sinus treated. The doctor did not get light confirmation and was having difficulty advancing the balloon and vortex catheter. The saline injected into the orbit during irrigation. No other procedures were conducted at that time and there was no surgery required to reduce swelling.
Patient Sequence No: 1, Text Type: D, B5
[11808544]
Vp of medical affairs tried to contact the treating physician by phone three times but did not receive any response. Based on the information provided, there was not enough information to determine if acclarent devices cause or contribute to the event. There was no information provided if other medical intervention (e. G. Intravenous steroid) was performed. The subject device of this report was not returned for evaluation, and its whereabouts are unknown. Acclarent will continue to monitor this phenomenon for trending purposes. This report is being submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2014-00008 |
| MDR Report Key | 3736452 |
| Report Source | 05 |
| Date Received | 2014-04-03 |
| Date of Report | 2014-03-05 |
| Date Mfgr Received | 2014-03-05 |
| Date Added to Maude | 2014-04-11 |
| 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 NIELSION, 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 | KAM |
| Date Received | 2014-04-03 |
| 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, INC. |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-03 |