MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-14 for RELIEVA FLEX SINUS GUIDE CATHETER GC110RF manufactured by Acclarent.
[4734288]
It was reported that after dilating the right maxillary sinus the physician was about to insert the device into the left maxillary sinus when it was observed that the blue tip of the sinus guide catheter was missing. The physician examined the right maxillary sinus. The user reported that the tip was located inside a blood clot that had already been removed from the pt earlier in the same procedure. The guide was replaced and the procedure was successfully completed.
Patient Sequence No: 1, Text Type: D, B5
[12301447]
The device referenced is being returned for eval. Review of mfg records associated with the subject device did not detect any anomalies. A supplemental report will be submitted with the results of the eval following receipt of the device. Acclarent will continue to monitor this phenomenon for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2014-00020 |
| MDR Report Key | 4066676 |
| Report Source | 05 |
| Date Received | 2014-08-14 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-07-17 |
| Date Mfgr Received | 2014-07-18 |
| Device Manufacturer Date | 2013-04-01 |
| Date Added to Maude | 2014-09-11 |
| 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 | IZABEL NIELSON, SR. MGR, POST MA |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506874924 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA FLEX SINUS GUIDE CATHETER |
| Generic Name | FLEX GUIDE CATHETER |
| Product Code | KAM |
| Date Received | 2014-08-14 |
| Model Number | NA |
| Catalog Number | GC110RF |
| Lot Number | 130403E-CM |
| ID Number | NA |
| Device Expiration Date | 2015-04-03 |
| 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 |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-14 |