MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-11-11 for AINTREE INTUBATION CATHETER N/A C-CAE-19.0-56-AIC manufactured by Cook Inc.
[59786040]
Blank fields on this form indicate the information is unknown or unavailable. (b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[59786041]
The aic was loaded over the fiberoptic bronchoscope and then passed through the clma into the trachea. After confirmation of tracheal placement with the fiberscope, the fiberscope and lma were removed, leaving the aic at the 34 cm mark at the mouth angle. Another manufacturer's endotracheal tube was then introduced over the aic. Unfortunately, the aic broke at the level of the mouth angle and was left in the trachea. The patient regained spontaneous breathing at this time and 3. 0 l/min of oxygen was administered by nasal cannula. The facility tried to extract the aic by endoscope, but failed due to the slippery surface of the sheared aic. Ventilation was maintained again by clma. A surgical airway (tracheostomy) was established to remove the aic. Following removal, retrograde insertion of a 16-french nasogastric tube was performed through the orifice of the tracheostomy to the oral cavity. The nasogastric tube served as an introducer and guided the ett into the trachea. The operation progressed smoothly and the patient was discharged uneventfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-01294 |
| MDR Report Key | 6096892 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-11-11 |
| Date of Report | 2017-09-05 |
| Date Mfgr Received | 2017-08-30 |
| Date Added to Maude | 2016-11-11 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AINTREE INTUBATION CATHETER |
| Product Code | BWC |
| Date Received | 2016-11-11 |
| Model Number | N/A |
| Catalog Number | C-CAE-19.0-56-AIC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-11 |