MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-05-12 for NONE manufactured by Acclarent, Inc..
[1488291]
This event occurred in one pt. Acclarent was made aware of this event on 4/12/2010. A pt had a csf-leak in the right frontal sinus after a hybrid case involving fess, an anterior ethmoidectomy, as well as balloon sinuplasty. The complaint information noted placement of the solo pro balloon in the right frontal sinus appeared odd. Consequently, the surgeon performed a ct scan, concluding the guidewire and balloon were advanced posterior to the frontal sinus. The pt was treated with gel foam and glue to resolve the leak. The pt was placed with a lumbar drain. No evidence of a persistent leak was noted shortly thereafter.
Patient Sequence No: 1, Text Type: D, B5
[8468849]
The information available did not mention whether the pt had a previous history of injury, or any pre-existing anatomical defects. It did, however, state that the pt had a longer than normal uncinate process, in addition to a small right frontal sinus in relation to the left frontal sinus. It is unk what other surgical instruments may have been used to perform the ethmoidectomy noted in the complaint report. A review of the historical trending was performed for csf leak, and no significant trends were noted. In addition, no product malfunction was noted. The lot information was not available. No device (s) were available for return. Acclarent will continue to update the file with any additional information and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2010-00005 |
| MDR Report Key | 1689811 |
| Report Source | 05,07 |
| Date Received | 2010-05-12 |
| Date of Report | 2010-05-07 |
| Date of Event | 2010-04-09 |
| Date Added to Maude | 2010-05-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | KAM |
| Date Received | 2010-05-12 |
| 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. Required No Informationntervention | 2010-05-12 |