MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-02-25 for RELIEVA STRATUS MICROFLOW SPACER BC1417RS manufactured by Acclarent, Inc..
[3197348]
Acclarent was notified on (b)(6) 2013 of an event that occurred on (b)(6) 2013, during a sinus surgical case when acclarent balloon dilation technology was used. The surgeon performed a frontal sinus balloon sinuplasty with no difficulty. After that, he elected to insert an acclarent frontal sinus spacer bilaterally. He filled the spacer with triamincinalone which he knew was off-label use. Several days later, the pt snorted backwards and felt pain in the nose. She was certain she swallowed the spacer. The surgeon performed an office nasal endoscopic exam and could not see the spacer. The chest and abdominal x-rays were obtained and the surgeon discussed the event with a gastroenterologist and both agreed that since there were no symptoms, nothing more would be done. No further reported sequelae.
Patient Sequence No: 1, Text Type: D, B5
[10630100]
Acclarent followed-up on this report to gather additional information. Vp of medical affairs concluded that the frontal sinus spacer most likely dislodged both from the force of the snorting and the wide frontal recess from the previous surgery. There was no adverse event experienced by the pt other than the need for x-rays. The subject device of this report was not returned for eval and its whereabouts are unk. Acclarent will continue to monitor this phenomenon for trending purposes. This report is being submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2013-00004 |
| MDR Report Key | 3012921 |
| Report Source | 05 |
| Date Received | 2013-02-25 |
| Date of Report | 2013-01-28 |
| Date of Event | 2013-01-23 |
| Date Mfgr Received | 2013-01-28 |
| Date Added to Maude | 2013-05-03 |
| 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 | NOOSHIN ASBAGH |
| 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 SPACER |
| Product Code | KAM |
| Date Received | 2013-02-25 |
| Model Number | NA |
| Catalog Number | BC1417RS |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2013-02-25 |