MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-04-11 for RELIEVA SINUS BALLOON CATHETER SYSTEM UNK manufactured by Acclarent, Inc..
[4466062]
Acclarent was made aware of this event on 03-31-2014 when a comment was posted on the acclarent (b)(4). The comment mentioned that the pt had the balloon sinuplasty procedure by a physician in (b)(6). Few days after the procedure, the pt was admitted to (b)(6) with a cerebrospinal fluid leak caused by the physician, who perforated the ethmoid roof. The head and neck surgeon made a patch from the behind the pt's ear and patch is healing nicely but now the pt alleged experiencing vision problem.
Patient Sequence No: 1, Text Type: D, B5
[11766396]
Vp of medical affairs reviewed the post and concluded that there was not enough information to know if the acclarent devices were part of the surgery. The post indicated that the pt had balloon sinuplasty procedure but there are many surgeons using any balloon from any mfr and use balloon sinuplasty this term. Per vp of medial affairs comment, it is highly csf leak. More likely is that the case was hybrid case (balloon sinuplasty procedure plus traditional tools). Acclarent regional mgr confirmed that there were no csf leak events that she was aware of. There are no evidences that the acclarent devices cause or contribute to the reported event. This report is being submitted in an abundance of caution. The subject device of this report was not returned for evaluation, and its whereabouts are unk. Acclarent will continue to monitor this phenomenon for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2014-00009 |
| MDR Report Key | 3761017 |
| Report Source | 00 |
| Date Received | 2014-04-11 |
| Date of Report | 2014-03-31 |
| Date Mfgr Received | 2014-03-31 |
| Date Added to Maude | 2014-04-22 |
| 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 MGR |
| 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 SINUS BALLOON CATHETER SYSTEM |
| Generic Name | SINUS BALLOON CATHETER |
| Product Code | KAM |
| Date Received | 2014-04-11 |
| Model Number | NA |
| Catalog Number | UNK |
| 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. Required No Informationntervention | 2014-04-11 |