MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-03 for RELIEVE FLEX SINUS GUIDE CATHETER GC110RF manufactured by Acclarent.
[21970962]
Acclarent was notified on (b)(6) 2013 of an event during a sinus surgical case when acclarent balloon dilation technology was used. The physician tried to access the right maxillary sinus and the blue tip came off. The physician was able to retrieve the detached tip. There was no pt injury.
Patient Sequence No: 1, Text Type: D, B5
[22209688]
Complaint devices arrived on (b)(6) 2013 and failure analysis was performed on (b)(6) 2013. The returned package included a flex guide catheter. The blue tip was detached from the guide catheter. The detached tip returned with the package. It is suspected that the damage could be the result of excessively aggressive use by the surgeon. 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 | 3005172759-2014-00001 |
| MDR Report Key | 3757368 |
| Report Source | 05 |
| Date Received | 2014-01-03 |
| Date of Report | 2013-12-16 |
| Date of Event | 2013-12-17 |
| Date Mfgr Received | 2013-12-16 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2014-05-27 |
| 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 | MONICA BARRETT |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506874948 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVE FLEX SINUS GUIDE CATHETER |
| Generic Name | FLEX GUIDE CATHETER |
| Product Code | KAM |
| Date Received | 2014-01-03 |
| Returned To Mfg | 2013-12-30 |
| Model Number | NA |
| Catalog Number | GC110RF |
| Lot Number | 120223F-CH |
| ID Number | NA |
| Device Expiration Date | 2014-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACCLARENT |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-03 |