MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-08-22 for VORTEX IRRIGATING CATHETER LC7065 manufactured by Acclarent, Inc..
[3049858]
The surgeon reported that during a balloon sinuplasty procedure in india, the subject device was used in a pt with ostiomeatal complex obstruction and sinusitis with complete opacification of the right maxillary sinus. After the maxillary dilation procedure and irrigation, thick viscid material came out of the maxillary sinus and pt immediately developed proptosis of the right eye. A medial decompression of the orbit carried out to relieve eye pressure. Pt was given a dose of intravenous methyl prednisolone and the pt was observed for three days and discharged. The pt was followed up after 10 days and there were no long term sequelae.
Patient Sequence No: 1, Text Type: D, B5
[10157120]
Acclarent followed up on this report to gather additional info. A retrospective review of the ct scans by radiologist revealed that there was a dehiscence in the anterior part of the lamina with general thinning of the bone. This was most likely caused by the chronic infection in the region. The surgeon reported that the orbital swelling was in no way caused by the acclarent tools which performed satisfactorily. The subject device of this report was not returned for eval, and its whereabouts are unk. Acclarent will continue to monitor this phenomenon for trending purposes. The vortex instructions for use state, under the warnings section, "to prevent inadvertent fluid extravasation, such as into the orbit, do not irrigate in the presence of a bony dehiscence or defect in any sinus wall. " this report is being submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2012-00029 |
| MDR Report Key | 2717729 |
| Report Source | 05 |
| Date Received | 2012-08-22 |
| Date of Report | 2012-07-29 |
| Date of Event | 2012-04-30 |
| Date Mfgr Received | 2012-07-29 |
| Date Added to Maude | 2012-08-29 |
| 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, DIR. |
| 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 | 2012-08-22 |
| Model Number | LC7065 |
| 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; 2. Required No Informationntervention | 2012-08-22 |