MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-05-16 for COBRA? FUSION? 150 ABLATION SYSTEM 001-700-001S manufactured by Atricure, Inc..
[145368644]
(b)(4) the device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number for the cobra fusion was not reported or able to be subsequently ascertained. The complaint could not be confirmed. There was no report of any device malfunction. This was a procedural complication.
Patient Sequence No: 1, Text Type: N, H10
[145368645]
It was reported on (b)(6) 2019 that a patient underwent an on-pump coronary artery bypass graft surgery with box lesion set and left atrial appendage (laa) management procedure. The patient was fully heparinized. Prior to procedure, transesophageal echocardiography confirmed that there was no clot in laa. The surgeon used the cobra fusion 150 device to open the transverse and oblique sinuses. The surgeon completed the first ablation cycle from left pulmonary veins through oblique sinus toward the right pulmonary veins. For the second set of ablations, the frame was shifted from the oblique toward the right pulmonary veins toward the roof line through the transverse sinus. The surgeon completed the first cycle-bipolar then switched to monopolar and completed set of ablations. An atriclip ach240 was then used for left laa management and followed with the coronary artery bypass grafting procedure. Post-procedure, during recovery, it was noted that the patient was paralytic on his left side. A computed tomography scan (cat) scan confirmed an embolic stroke and the patient was placed on a stroke activation treatment protocol. Patient has been discharged but discharge date is unknown; patient is undergoing rehabilitation therapy for some residual effects of weakness on his left side but is expected to fully recover. There was no report of any device malfunction or procedure complication. This was a procedural complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00027 |
| MDR Report Key | 8617731 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-05-16 |
| 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 JOHN EHLERT |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5137554563 |
| Manufacturer G1 | ATRICURE, INC. |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBRA? FUSION? 150 ABLATION SYSTEM |
| Generic Name | COBRA? FUSION? 150 ABLATION SYSTEM |
| Product Code | OCL |
| Date Received | 2019-05-16 |
| Model Number | 001-700-001S |
| Catalog Number | 001-700-001S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE, INC. |
| Manufacturer Address | 7555 INNOVATION WAY MASON OH 45040 US 45040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2019-05-16 |