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 2019-04-24 for EPI-SENSE GUIDED COAGULATION SYSTEM WITH VISITRAX CDK-1413 CDK-1413-EU manufactured by Atricure, Inc..
[142930288]
(b)(4). The episense device lot number 87117 was returned and evaluated. The complaint was confirmed for zero flow within the flow limiter at the perfusion port. There was no adverse event reported.
Patient Sequence No: 1, Text Type: N, H10
[142930289]
It was reported on (b)(6) 2019 that a patient underwent a convergent procedure. Patient was off-pump and heparinized. During the procedure, the temperature on the temperature probe suddenly rose up to 40c. After cooling down for another lesion; the event happened again. It was recognized that the saline perfusion through the device was not working properly. The probe was exchanged for a new device and the procedure was completed. There were no adverse effects on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00023 |
| MDR Report Key | 8543898 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-02-21 |
| Date Mfgr Received | 2019-03-28 |
| Device Manufacturer Date | 2018-10-02 |
| Date Added to Maude | 2019-04-24 |
| 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 | 2019-04-24 |
| Returned To Mfg | 2019-03-25 |
| Model Number | CDK-1413 |
| Catalog Number | CDK-1413-EU |
| Lot Number | 87117 |
| 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 | 2019-04-24 |