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 2019-05-14 for EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX CDK-1413 manufactured by Atricure, Inc..
[144946417]
Case- (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 epi sense device was not reported or able to be subsequently ascertained. The complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[144946418]
It was reported on (b)(6) 2019 a (b)(6) year-old female patient underwent a staged convergent ablation procedure. Prior to the procedure, a trans-esophageal echocardiogram was performed, there was no evidence of clots within the left atrial appendage and left atrium. A temperature probe was placed prior to the procedure. Patient was not heparinized for the procedure. The surgeon completed the procedure as anticipated and noted that the patient had a? Large atrium?. During procedure, there were no report of any device malfunction or procedural complications. Patient was discharged on (b)(6) 2019 in stable condition. On (b)(6) 2019 the patient was not feeling well and was admitted to (b)(6) hospital where she was found to be pulseless and resuscitated. On (b)(6) 209 patient coded and expired. The surgeon did not believe that an autopsy was performed but, thinks that the patient may have died from a pulmonary embolus. This was a procedural complication. There was no reported device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00026 |
| MDR Report Key | 8607320 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-16 |
| Date Added to Maude | 2019-05-14 |
| 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 | EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX |
| Generic Name | EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX |
| Product Code | OCL |
| Date Received | 2019-05-14 |
| Model Number | CDK-1413 |
| Catalog Number | CDK-1413 |
| Lot Number | UNKNOWN |
| 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. Death | 2019-05-14 |