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 2019-04-19 for EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX CDK-1413 manufactured by Atricure, Inc..
[142515001]
(b)(4) the episense device was discarded by the facility and a evaluation could not be performed but a device history review was obtained for lot number 85624. There is nothing in the device history record that would indicate that the devices were released with any non-conformances that would contribute to the complaint.
Patient Sequence No: 1, Text Type: N, H10
[142515002]
It was reported on (b)(6) 2019 that a (b)(6)-year-old female patient underwent an off-pump convergent surgical procedure with left atrial appendage (laa) management. A pre-procedure transesophageal echocardiogram (tee) was conducted and no clots were in the left atrial appendage. The patient was not heparinized for the procedure. The posterior wall ablations went normal, although some adhesions were present from prior catheter ablations. Patient also had a history of mini mitral valve repair. The atriclip placement was a little more challenging as the laa had to be detached from the heart due to the adhesions. The surgeon could not place an atriclip prov but was able to successfully place an atriclip pro250. Approximately one week later, the patient experienced a stroke with slight issues with speaking and memory. The patient is recovering well. This was a procedural complication. There was no reported device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00020 |
| MDR Report Key | 8532250 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-19 |
| Date of Report | 2019-04-19 |
| Date Mfgr Received | 2019-03-22 |
| Device Manufacturer Date | 2017-02-02 |
| Date Added to Maude | 2019-04-19 |
| 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 | 2019-04-19 |
| Model Number | CDK-1413 |
| Catalog Number | CDK-1413 |
| Lot Number | 85624 |
| 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 | 2019-04-19 |