MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-31 for RELIEVA FLEX SINUS GUIDE CATHETER F-70C GC070CRF manufactured by Acclarent.
[20732010]
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 left maxillary sinus recess, the balloon leaked and could not be inflated, after having treated five other sinuses successfully. Analysis of the returned product was completed on 12/05/2014 and revealed that the distal blue tip of the sinus guide catheter detached from the nylon shaft and was stuck inside the shaft. On 12/18/2014, it was confirmed that the physician had identified the tip detachment at the end of the procedure, after dilating the left frontal sinus and removing the balloon catheter. The physician checked and confirmed that no debris remained in the patient's sinus recess. No patient injury was reported as a result of the tip detaching and being stuck in the nylon shaft.
Patient Sequence No: 1, Text Type: D, B5
[20944746]
Review of manufacturing records associated with the subject devices did not detect any manufacturing anomalies. Acclarent will continue to monitor this phenomenon for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2014-00033 |
| MDR Report Key | 4381567 |
| Report Source | 05 |
| Date Received | 2014-12-31 |
| Date of Report | 2014-12-05 |
| Date of Event | 2014-12-05 |
| Date Mfgr Received | 2014-12-05 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2015-01-14 |
| 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. MANAGER |
| 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 | 2014-12-31 |
| Returned To Mfg | 2014-11-07 |
| Model Number | F-70C |
| Catalog Number | GC070CRF |
| Lot Number | 131113D-CM |
| ID Number | NA |
| Device Expiration Date | 2015-11-13 |
| 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 | 2014-12-31 |