MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-02 for ARNDT ENDOBRONCHIAL BLOCKER SET N/A C-AEBS-9.0-78-SPH manufactured by Cook Inc.
[153694081]
Pma/510(k) #: k160542. 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
[153694082]
It was reported that the balloon on a arndt endobronchial blocker set would not inflate and hold shape during a lung procedure. The bronchial blocker was placed in a single lumen tube from the package. The clinical team placed the balloon inside the lung in a one lung ventilation case. After placement the team attempted to fill the balloon, however, it would not inflate and hold shape. The device was removed from the patient and the balloon was visually inspected. The balloon appeared to be punctured or torn. A different blocker was used successfully in the patient. The arndt endobronchial blocker was not tested prior to being placed in the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01926 |
| MDR Report Key | 8855770 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-02 |
| Date of Report | 2019-09-24 |
| Date of Event | 2019-07-11 |
| Date Mfgr Received | 2019-09-19 |
| Device Manufacturer Date | 2019-03-18 |
| Date Added to Maude | 2019-08-02 |
| 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 | MR. LARRY POOL |
| 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 | ARNDT ENDOBRONCHIAL BLOCKER SET |
| Generic Name | CBI TUBE, TRACHEAL/BRONCHIAL |
| Product Code | CBI |
| Date Received | 2019-08-02 |
| Returned To Mfg | 2019-07-23 |
| Model Number | N/A |
| Catalog Number | C-AEBS-9.0-78-SPH |
| Lot Number | 9597903 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-08-02 |