MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-08-25 for NOT DEVICE SPECIFIC/NO DEVICE MALFUNCTION manufactured by .
[21423507]
Acclarent was made aware of an event on (b)(6) 2011 involving a (b)(6) female with extensive sinus and nasal polyps causing chronic sinusitis. The following case feedback was noted from discussion with the acting physician: an acclarent relieva balloon was inserted into the right frontal sinus and was dilated. Following successful dilation, acclarent's vortex irrigating catheter was used. Upon the fourth irrigation of saline at a low pressure, a thick discharge was noted to come from the sinus. At this time, the physician noted that the pt's right eye appeared proptotic (condition resulting in forward displacement). The tonometric eye pressure was noted as 60mm. A lateral canthotomy (incision near the eyelid to relieve pressure) was performed and the pressure came down to 30mm. There was no change in vision and no double vision. Hospitalization was not required. The pt is doing well with good healing of the sinuses and no ophthalmologic problem. The physician noted that the acclarent guide, guidewires, balloons and irrigating catheter performed without problem, and that the proptosis and need for lateral canthotomy related to the extensive pathology causing bone erosion. This unique pt anatomy permitted the irrigating fluid to track from the sinus into the orbit. The physician noted that this was not device related and could have occurred with traditional surgery. Acclarent will continue to update the file with additional info and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: D, B5
[21522020]
No device malfunction was noted. Acclarent's devices were noted to have performed without fault and as expected. The devices used were not available for eval. No lot info was provided. Acclarent will continue to update the file with any add'l info and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2011-00008 |
| MDR Report Key | 2232600 |
| Report Source | 07 |
| Date Received | 2011-08-25 |
| Date of Report | 2011-08-23 |
| Date of Event | 2011-05-01 |
| Date Added to Maude | 2011-09-06 |
| 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 | MARK BISHOP, VP |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875843 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOT DEVICE SPECIFIC/NO DEVICE MALFUNCTION |
| Generic Name | NA |
| Product Code | KAM |
| Date Received | 2011-08-25 |
| Model Number | NA |
| Catalog Number | NA |
| Lot 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-08-25 |