MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-11-15 for INSPIRA AIR BALLOON CATHETER 5X24MM BC0524A manufactured by .
[21281823]
This event occurred in one patient and involved a (b)(6) who was born premature at (b)(6) gestation. At the time of birth, the infant had stridor and some airway distress and needed to be intubated two days after birth. Because of persistent airway symptoms and the diagnosis of subglottic stenosis, a decision was made to dilate the airway using the inspira air acclarent balloon system. While subglottic stenosis was seen, there appeared to be adequate room to insert a balloon to dilate the stenotic segment. The smallest inspira air balloon was used (5x24 mm) without using a stylet. The balloon was easily passed into the larynx and into the subglottic stenotic region. It was inflated to 8 atm pressure for 30 seconds. Oxygen saturations were very good throughout the dilation. While the balloon was deflated, oxygen was noted to be given through the stylet portion of the balloon, using a very low flow at 2 liters. When the balloon was removed, there was no blood on it, indicating minimal if any trauma to the tissue. At this point the child experienced laryngospasm and was intubated with a 3. 5 mm endotracheal tube. The child could not be ventilated, and the oxygen saturation decreased. A chest x-ray indicated pneumomediastinum and pneumopericardium. An emergency thoracotomy and pericardial window were created to stop the tamponade of the heart. One week later a tracheotomy was performed and the child was stable, sedated and on a respirator. The inspira air device was not available for return. No product malfunction was noted by the physicians.
Patient Sequence No: 1, Text Type: D, B5
[21347121]
Acclarent's (b)(4) spoke by telephone with both the acting physician, as well as an observing physician. Both felt the inspira air system functioned properly and the device was not the source of the pneumomediastinum and pneumopericardium, but rather the free air in chest occurred during the ventilation of the child. The acting physician believes there may have been a small tear in the mucosa perhaps when ventilating the patient with the mask in preparation for the dilation or during the laryngospasm. Through this tear, air could have leaked into the mediastinum. Although unable to determine an exact root cause, acclarent's (b)(4) feels the suspected root cause to be due to either the oxygen given via mask during laryngospasm, the ventilation to prepare the child for the dilation, or to the ventilation provided thru the inspira air stylet port. It should be noted that the inspira air balloon catheter is not intended to be used with ventilation. No instances of such use of inspira air have been previously communicated to acclarent. As a precautionary measure acclarent will update the ifu with a warning to the labeling, stating "do not connect oxygen or ventilate through the stylet port. " acclarent will continue to update the file with any additional information and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005172759-2010-00012 |
| MDR Report Key | 1903501 |
| Report Source | 07 |
| Date Received | 2010-11-15 |
| Date of Report | 2010-10-21 |
| Date of Event | 2010-10-11 |
| Date Added to Maude | 2010-11-23 |
| 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 | MARK BISHOP, VP |
| Manufacturer Street | 1525-B O'BRIEN DR. |
| Manufacturer City | MENLO PARK CA 94025 |
| Manufacturer Country | US |
| Manufacturer Postal | 94025 |
| Manufacturer Phone | 6506875843 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSPIRA AIR BALLOON CATHETER 5X24MM |
| Generic Name | INSPIRA AIR 5X24MM |
| Product Code | KAM |
| Date Received | 2010-11-15 |
| Model Number | 5X24MM |
| Catalog Number | BC0524A |
| Lot Number | 100512A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2010-11-15 |