MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-05 for RELIEVA FLEX SINUS GUIDE CATHETER F-70C GC070CRFZ manufactured by Acclarent.
[5176242]
Acclarent was informed of an event that was said to have occurred during a procedure in which relieva flex sinus guide catheters were said to have been used. The user facility reported that during a balloon sinuplasty of the maxillary sinus recess, the distal blue end of the sinus guide catheter detached from the distal end of the catheter. At the time of the procedure, the physician identified the detachment and visualized the detached tip with an endoscope. The detached tip was recovered by the physician using an unknown pair of surgical forceps. A second flex sinus guide catheter was used and it too reportedly detached and was recovered using forceps. No patient injury was reported in either of these 2 instances of tip separation, however the physician elected to abandon the balloon sinuplasty procedure after the second occurrence and the patient was treated with functional endoscopic sinus surgery (fess).
Patient Sequence No: 1, Text Type: D, B5
[12627878]
The subject devices are being returned for evaluation. Review of manufacturing records associated with the subject devices did not detect any manufacturing anomalies. A supplemental report will be submitted with the results of the evaluation following receipt of the devices. Acclarent will continue to monitor this phenomenon for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2014-00032 |
| MDR Report Key | 4345442 |
| Report Source | 05 |
| Date Received | 2014-12-05 |
| Date of Report | 2014-11-07 |
| Date of Event | 2014-11-07 |
| Date Mfgr Received | 2014-11-07 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2014-12-24 |
| 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 |
| 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 | SINUS GUIDE CATHETER |
| Product Code | KAM |
| Date Received | 2014-12-05 |
| Model Number | F-70C |
| Catalog Number | GC070CRFZ |
| Lot Number | 120814D-CM |
| ID Number | NA |
| Device Expiration Date | 2014-08-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-12-05 |