MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-18 for VORTEX IRRIGATING CATHETER LC7065 manufactured by Acclarent, Inc..
[3259268]
Acclarent was notified on (b)(6) 2013, of an event that occurred on (b)(6) 2013, during a sinus surgical case when acclarent balloon dilation technology were used. An acclarent spin device was used to dilate right maxillary sinus with no difficulty. The acclarent vortex irrigating catheter was used to enter the dilated maxillary sinus ostia. When initiating irrigation, the operating room assistant said that the fluid was going very slowly and was meeting resistance. The irrigating catheter was pulled back and the irrigating fluid entered the sinus more easily. The right cheek and eyelid were noted swell. The irrigation was stopped. The endoscope revealed a small tear in the mucosa of the roof of the maxillary sinus. The surgeon asked for an ophthalmologist to the operation room and found the intraocular pressures normal. Within 10 minutes, the eyelid swelling began to diminish. The patient was kept overnight and by the next day, nearly all of the swelling was gone. There was never any vision change.
Patient Sequence No: 1, Text Type: D, B5
[10638146]
Acclarent followed up on this report to gather additional information. The surgeon indicated that irrigating catheter caused a small mucosal tear and irrigating fluid traversed into the soft tissue. The vp of medical affairs concluded that the eye and cheek swelling appeared to come from the extravasated irrigation fluid. This resolved on its own and precaution was taken to obtain an opthalmaologic examination and observe and keep the patient overnight. 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 | 3005172759-2013-00010 |
| MDR Report Key | 3030579 |
| Report Source | 05 |
| Date Received | 2013-03-18 |
| Date of Report | 2013-02-27 |
| Date of Event | 2013-02-27 |
| Date Mfgr Received | 2013-02-27 |
| Date Added to Maude | 2013-04-03 |
| 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 | NOOSHIN ASBAGH, DIRECTOR |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875398 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VORTEX IRRIGATING CATHETER |
| Generic Name | IRRIGATION CATHETER |
| Product Code | KAM |
| Date Received | 2013-03-18 |
| Model Number | NA |
| Catalog Number | LC7065 |
| 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 | 1. Hospitalization | 2013-03-18 |