MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-02 for INSPIRA AIR BALLOON DILATION SYSTEM 18X40MM BC1840A manufactured by Acclarent, Inc..
[2816265]
Acclarent received a report that the subject device was used in a procedure to expand the airway in a pt with moderate to severe acquired tracheal stenosis. The physician initially lasered several incisions into the tracheal scar and mucous membrane of the pt's airway. The balloon was placed in the airway and the site dilated for 1-2 minutes. The physician reported there was more damage to the airway mucosa than what he expected following deflation. An x-ray was performed, and showed no free air in the chest or mediastinum, and the pt was admitted to the user facility for observation overnight. Following the event the pt was said to be doing well.
Patient Sequence No: 1, Text Type: D, B5
[10017778]
Acclarent followed up on this report and contacted the reporting physician. The physician reported that he has specifically selected a large balloon for maximal dilatation, but had not measured the pt's airway prior to using the balloon. The pt was said to have been discharged the day following the event. The device reference in this report was not returned for evaluation. The exact cause of the reported temporary mucosal damage could not be determined. Based upon the information provided, the event may have been related to too large of a balloon being used for the airway. This event will be monitored for trending purposes. This report is being submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2012-00020 |
| MDR Report Key | 2654323 |
| Report Source | 05 |
| Date Received | 2012-07-02 |
| Date of Report | 2011-06-07 |
| Date of Event | 2011-06-03 |
| Date Mfgr Received | 2011-06-07 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSPIRA AIR BALLOON DILATION SYSTEM |
| Generic Name | AIRWAY BALLOON CATHETER |
| Product Code | KAM |
| Date Received | 2012-07-02 |
| Model Number | 18X40MM |
| Catalog Number | BC1840A |
| 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 | 1525-B O'BRIEN DR. MENLO PARK CA 94025 US 94025 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-07-02 |