MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-12-15 for INSPIRA AIR BALLOON CATHETER 5X24MM BC01040A manufactured by .
[18959782]
No prior case of negative pressure pulmonary edema has been noted. No device or lot info was available. No product malfunction was noted. Acclarent will continue to update the file with any additional info and provide subsequent reports if required.
Patient Sequence No: 1, Text Type: N, H10
[19100712]
On (b)(6) 2010, a physician from (b)(6) contacted acclarent's vp of medical affairs regarding an event associated with negative pressure pulmonary edema. The date of the procedure was noted as (b)(6) 2010, involving a pt with spontaneous breathing. In the recovery room, there was some coughing noted. A chest x-ray in recovery room showed fluffy pulmonary edema. After a long stay in recovery this condition improved, however, the pt was noted to still have a cough and reactive airway that was not there before. A diagnosis of negative pressure pulmonary edema was made. According to acclarent's vp of medical affairs, while the negative pressure pulmonary edema can theoretically occur from spontaneous breathing against the balloon, it is an extremely rare phenomenon. Acclarent's vp of medical affairs consulted another physician well versed in treating such cases. In over 1,500 cases of airway stenosis dilation, the consulted physician noted that he had never seen a case of negative pressure pulmonary edema. Furthermore, he noted that it is impossible to know how shallow or not the spontaneous breathing was. If the breathing was very shallow or the pt apneic, then the chance of negative pressure pulmonary edema from the balloon inflation is zero. Since this was not measured, it is difficult to know if the pulmonary edema occurred relative to the balloon or not.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005172759-2010-00013 |
| MDR Report Key | 1944266 |
| Report Source | 07 |
| Date Received | 2010-12-15 |
| Date of Report | 2010-10-21 |
| Date of Event | 2010-10-11 |
| Date Added to Maude | 2011-01-18 |
| 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 10X40MM |
| Product Code | KAM |
| Date Received | 2010-12-15 |
| Catalog Number | BC01040A |
| 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 | 2010-12-15 |