MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-22 for INSPIRA AIR BALLOON DILATION SYSTEM BC1040A manufactured by Acclarent.
[3110146]
The user facility reported a superficial mucosal tear of the trachea occurred during an airway dilatation procedure in which the subject device was used. The pt was being treated for subglottic and upper tracheal stenosis secondary to prolonged intubation. The area of stenosis was dilated using a catheter with a 10x40 mm balloon, with the pt's tracheostomy tube in place and ventilation provided through the tracheostomy tube. The surgeon reportedly noted some bleeding and immediately stopped the inflation. A cardiothoracic surgeon examined the pt, and endoscopy revealed a superficial posterior tracheal wall mucosal tear. A chest x-ray was negative for mediastinal air or pneumothorax. For precautionary purposes the pt was observed overnight and discharged the next morning. No further complications have been reported.
Patient Sequence No: 1, Text Type: D, B5
[10495148]
There was no report of product malfunction. The device was not returned for evaluation and its whereabouts are unk. Acclarent followed up with the user and was informed the selected balloon was likely too large for the procedure. The inspira air instructions for use warns that use of a balloon catheter that is too large for the targeted anatomy may cause damage to the surrounding anatomy, and also and instructs users to select a balloon size that does not exceed the expected diameter of a healthy airway. This report appears to be a case of user error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2012-00048 |
| MDR Report Key | 2887355 |
| Report Source | 05 |
| Date Received | 2012-12-22 |
| Date of Report | 2012-11-28 |
| Date of Event | 2012-11-28 |
| Date Mfgr Received | 2012-11-28 |
| Date Added to Maude | 2012-12-28 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | STEVE TIVEY |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506876050 |
| 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 | 2012-12-22 |
| Model Number | NA |
| Catalog Number | BC1040A |
| 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 |
| Manufacturer Address | 1525-B O'BRIEN DR. MENLO PARK CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-12-22 |