MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-07-02 for RELIEVA STRATUS MICROFLOW SPACER BC1417RS BC1417RX manufactured by Acclarent, Inc..
[2815777]
The physician reported that before a balloon sinuplasty procedure, he identified an acclarent relieva frontal stratus device in the left frontal sinus area, that the physician believed was implanted by another physician (b)(6) ago. There was some swelling and inflammation surrounding the area. The physician used forceps to explant the stratus device and he was able to dilated the sinus easily with acclarent balloon technology. The physician stated that there has been nothing unusual in the postoperative course during the follow up visit.
Patient Sequence No: 1, Text Type: D, B5
[10097235]
Implant date: (b)(6) before (b)(6) 2012. Acclarent followed up on this report and contacted the reporting physician. The physician stated that he had no explanation for the stratus not being removed since he was not the surgeon who placed the device, and he did not know the surgeon who performed the procedure. The was no serious adverse event or any consequences from the delayed removal of the stratus device. The physician indicated that the recurrence of polyps or inflammation noted was not related to the retained device but rather the nature of the disease itself. The physician stated all acclarent devices functioned as intended and the device in the reported event was not returned for evaluation and its whereabouts is unk. Acclarent will continue to monitor this phenomenon for trending purpose. This report is being submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2012-00025 |
| MDR Report Key | 2654320 |
| Report Source | 05,07 |
| Date Received | 2012-07-02 |
| Date of Report | 2012-03-29 |
| Date of Event | 2012-03-28 |
| Date Mfgr Received | 2012-03-29 |
| Date Added to Maude | 2012-08-07 |
| 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 Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875398 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA STRATUS MICROFLOW SPACER |
| Generic Name | STRATUS FRONTAL SPCER |
| Product Code | KAM |
| Date Received | 2012-07-02 |
| Model Number | BC1417RS |
| Catalog Number | BC1417RX |
| Lot Number | UNK |
| ID Number | NA |
| 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, INC. |
| Manufacturer Address | MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-07-02 |