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..
[1500966]
This event occurred in one pt approximately 6 months prior to acclarent's awareness of this event. Acclarent became aware of this event on (b) (6) 2010. A pt had a csf-leak in the frontal sinus after a hybrid case involving fess, as well as balloon sinuplasty with a solo balloon catheter. The information provided stated that the solo balloon catheter was not placed with an acclarent guide catheter, but rather, thru a suction device, without the guidance of a guidewire. Upon noting the csf leak, the pt was hospitalized. Resolution occurred shortly thereafter.
Patient Sequence No: 1, Text Type: D, B5
[8532658]
The information available did not mention whether the pt had any predisposing anatomical defect, injury history, or other factors that may have contributed to the injury. 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 | 3005172759-2010-00006 |
| MDR Report Key | 1689810 |
| Report Source | 05,07 |
| Date Received | 2010-05-12 |
| Date of Report | 2010-05-07 |
| 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 | 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 |
| 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. Hospitalization | 2010-05-12 |