MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-10-06 for RELIEVA VORTEX 2 SINUS IRRIGATION CATHETER RV02 manufactured by Acclarent.
[15814504]
Acclarent was informed of an event that occurred during a procedure in which an relieva spin balloon sinuplasty system and an acclarent vortex 2 irrigation catheter device were used. The physician had difficulty accessing the right frontal sinus using the spin device and used an unidentified frontal seeker to access the sinus. After the physician successfully dilated the sinus, the physician began irrigating the right frontal sinus using an acclarent vortex 2 irrigation catheter. During irrigation, the physician observed orbital fat bulging into the right frontal sinus recess and the patient's right eye swelling and leaking saline. The physician made an incision into the right eyelid to reduce the pressure and drain the excess saline, and called for an ophthalmic surgeon. The ophthalmic surgeon tested the pressure in the patient's right eye and confirmed to be normal. The physician then removed a portion of the protruding orbital fat from the nasal cavity and sutured up the incision made on the right eyelid. Patient was said to be fine after the procedure. Patient follow up occurred the following week and showed the patient is doing well with no further sequelae reported.
Patient Sequence No: 1, Text Type: D, B5
[16134734]
The subject device referenced in this report was discarded by the user facility and was not available for evaluation. Review of manufacturing records associated with the subject device did not detect any anomalies. The physician reported having no difficulties in using the acclarent device during or after the procedure. A supplemental report will be submitted if additional information is received, and acclarent will continue to monitor this phenomenon for trending purposes. See also mdr 3005172759-2014-00028 for a related report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2014-00027 |
| MDR Report Key | 4151913 |
| Report Source | 05 |
| Date Received | 2014-10-06 |
| Date of Report | 2014-09-10 |
| Date of Event | 2014-09-10 |
| Date Mfgr Received | 2014-09-10 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2014-10-09 |
| 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. MANAGER |
| Manufacturer Street | 1525-B O'BRIEN DRIVE |
| 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 | IRRIGATIION CATHETER |
| Product Code | KAM |
| Date Received | 2014-10-06 |
| Model Number | NA |
| Catalog Number | RV02 |
| Lot Number | 140108K-CM |
| ID Number | NA |
| Device Expiration Date | 2017-01-08 |
| 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 | 2014-10-06 |