MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-11-12 for RELIEVA SPIN SINUS GUIDE CATHETER TIP RSF70 manufactured by Acclarent.
[4987535]
Acclarent was informed of an event that occurred during a procedure in which a relieva spin balloon sinuplasty system was used. After successfully dilating the left frontal sinus, the physician inserted the relieva spin f-70 sinus guide catheter tip into the right frontal sinus and noticed that the distal blue end of the sinus guide catheter tip was missing. The physician located the missing portion near the left maxillary sinus and retrieved it by using bayonet forceps. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[12517063]
The subject device is being returned for evaluation. Review of manufacturing records associated with the subject device did not detect any anomalies. A supplemental report will be submitted with the results of the evaluation 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 | 3005172759-2014-00031 |
| MDR Report Key | 4253401 |
| Report Source | 05 |
| Date Received | 2014-11-12 |
| Date of Report | 2014-10-13 |
| Date of Event | 2014-10-13 |
| Date Mfgr Received | 2014-10-13 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2014-11-19 |
| 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 SPIN SINUS GUIDE CATHETER TIP |
| Generic Name | SINUS GUIDE CATHETER |
| Product Code | KAM |
| Date Received | 2014-11-12 |
| Model Number | NA |
| Catalog Number | RSF70 |
| Lot Number | 130917E-CM |
| ID Number | NA |
| Device Expiration Date | 2015-09-17 |
| 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 | 2014-11-12 |