MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-07-02 for RELIEVA STRATUS DEPLOYMENT GUIDE GC020RS manufactured by Acclarent, Inc..
[2685567]
The user facility reported that during a bi-lateral ethmoid sinus procedure, the physician attempted to place an ethmoid sinus spacer in the right side, however, the spacer deployment guide deflected off of unexpectedly hard bone, and inadvertently perforated the posterior ethmoid roof. The physician immediately detected a csf leak, and the pt was treated with a mucosal graft and tissue glue were applied. The pt was kept overnight, and discharged the following morning. On f/u six days later, the pt was said to be doing well.
Patient Sequence No: 1, Text Type: D, B5
[10071338]
Acclarent f/u on this report to gather add'l info on (b)(4) 2010. The physician indicated that he believed the pt's anatomy was the cause of the reported difficulty, as the pt had dense bone and a plate that was difficult to assess on ct scan. The anatomy reportedly deflected the trajectory of the guide internally. The device in the reported event was not returned for eval and its whereabouts is unk. Production records were reviewed and no deviations were noted that would likely cause or contribute to the reported event. 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 | 3005172759-2012-00017 |
| MDR Report Key | 2647842 |
| Report Source | 05,06 |
| Date Received | 2012-07-02 |
| Date of Report | 2010-05-26 |
| Date of Event | 2010-05-26 |
| Date Mfgr Received | 2010-05-26 |
| Date Added to Maude | 2012-07-11 |
| 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 | 6506875888 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELIEVA STRATUS DEPLOYMENT GUIDE |
| Generic Name | DEPLOYMENT GUIDE |
| Product Code | KAM |
| Date Received | 2012-07-02 |
| Model Number | GC020RS |
| Catalog Number | GC020RS |
| Lot Number | 08103D |
| ID Number | NA |
| Device Expiration Date | 2010-06-04 |
| 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 | 1525-B O'BRIEN DR. MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2012-07-02 |