MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-03 for COOK AIRWAY EXCHANGE CATHETER N/A UNKNOWN manufactured by Cook Inc.
[173646115]
Date of death: the patient was reported to have died "a few weeks" after the event. Exact date of death is currently unknown. Pma/510(k) #: exempt. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[173646116]
It was initially reported that the customer had "an incident" with an aintree intubation catheter. The incident was with the catheter, which was reported to have been "put [through] a tracheotomy stoma" and then "jet ventilated". Additional information confirmed that the device was "used to aid with a tracheostomy change in theatre". A manujet ventilation device was attached to the catheter via a rapid-fit adapter (which is supplied with the aintree intubation catheter). Jet ventilation was used while the new tracheal tube was inserted. The patient was then reported to have coughed. Immediately, the patient deteriorated and suffered from bilateral pneumothoraxes and cardiac arrest. Bilateral needle decompressions and subsequent chest drain insertions led to the return of circulation. However, the patient ultimately had a severe hypoxic brain injury and died a few weeks following the event. The cause of the severe hypoxic brain injury and death is unconfirmed at this time. Additional information regarding the patient, event, and device has been requested but is unavailable at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00052 |
| MDR Report Key | 9547482 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-03 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2019-02-08 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER CANADA |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC. |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK AIRWAY EXCHANGE CATHETER |
| Generic Name | LRC CHANGER, TUBE, ENDOTRACHEAL |
| Product Code | LRC |
| Date Received | 2020-01-03 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Death | 2020-01-03 |