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 2019-04-12 for EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX CDK-1413 manufactured by Atricure, Inc..
[145526203]
(b)(4) the epi-sense device lot number 88524 was returned and evaluated. The complaint was confirmed for zero flow within the flow limiter at the perfusion port.
Patient Sequence No: 1, Text Type: N, H10
[145526204]
It was reported that on (b)(6) 2019 a patient underwent a convergent procedure with left atrial appendage management. Upon initial set up of the epi-sense device, the saline drip was hooked up to the tear drop on the device and suction turned on, but no saline was pulling through the system. The connections to the device was confirmed, the saline was unhooked from the device, confirmed saline flow through tubing and reapplied tubing to device. Once again, there was no saline flow and at that point, the epi-sense device was exchanged out for a new device using the same tubing as before. The new epi-sense device functioned normally and the procedure was completed. The case was delayed one minute to troubleshoot and change out the device. The procedure was completed as anticipated with no adverse effects on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00017 |
| MDR Report Key | 8511108 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-14 |
| Date Mfgr Received | 2019-03-14 |
| Device Manufacturer Date | 2018-11-16 |
| Date Added to Maude | 2019-04-12 |
| 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 | 2019-04-12 |
| Returned To Mfg | 2019-04-01 |
| Model Number | CDK-1413 |
| Catalog Number | CDK-1413 |
| Lot Number | 88524 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2019-04-12 |