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 2017-12-01 for COSEAL 934074 manufactured by Baxter Healthcare - Hayward.
[93487594]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[93487595]
A patient passed away due to a post-operative bleed after undergoing an emergency open aneurysm surgery in which coseal was used as the only means of hemostasis. The coseal (4 ml) was used standalone, as there was no access to a spray system in the theatre. It was reported that the area of coseal application was oozy and not clean and dry. Subsequently, the patient experienced a post-operative bleed and was taken back to surgery on the following day where the patient died due to extensive bleeding reported as "there was a belly full of blood" and it was claimed "the product did not work". It was reported that coseal was used for this emergency surgery without any product training of the surgeon or of the operating room nurse on staff that day. At the time of this event, a product training was scheduled to take place eight days later, however, this event occurred prior to the scheduled training. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[96702561]
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. It was reported that coseal was used as the only method to achieve hemostasis. Coseal should be used as an adjunct. Coseal is not intended to replace sutures, ligatures or conventional surgical techniques. Per instructions for use, coseal should be used on a clean dry surface, not on an area of active bleeding. Additionally, coseal needs to be used under certain conditions (pressure for the spray set, height, and thin layer). Upon review of the information provided, it has been determined that a use error occurred. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2017-09500 |
| MDR Report Key | 7075589 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-01 |
| Date of Report | 2018-01-08 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2017-12-21 |
| Date Added to Maude | 2017-12-01 |
| 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 Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - HAYWARD |
| Manufacturer Street | 2024 W WINTON AVE |
| Manufacturer City | HAYWARD CA 94545 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94545 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COSEAL |
| Generic Name | SEALANT,POLYMERIZING |
| Product Code | NBE |
| Date Received | 2017-12-01 |
| Model Number | NA |
| Catalog Number | 934074 |
| Lot Number | HA170321 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - HAYWARD |
| Manufacturer Address | HAYWARD CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2017-12-01 |