MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-01-16 for COOLRAIL LINEAR PEN MCR1 A000625 manufactured by Atricure, Inc..
[178352517]
Case (b)(4). The device was not returned for evaluation, but a device history review was obtained for lot number 91616. 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
[178352518]
It was reported on 18-dec-2019, that a (b)(6) female patient who was enrolled in the deep clinical study, underwent the epicardial portion of the procedure on (b)(6) 2019. On post-op day 6 the patient experienced a pleural effusion. The patient was prescribed medication (bumex) and discharged. During a follow-up visit on (b)(6) 2019, patient was still experiencing shortness of breath and taking medications. A thoracentesis was performed on (b)(6) 2019 and 800ml of serous fluid was drained. A chest x-ray confirmed the pleural effusion was resolved. There was no reported device malfunction, and the adverse event was the result of a procedural complication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2020-00002 |
| MDR Report Key | 9597854 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-01-16 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-09 |
| Date Mfgr Received | 2019-12-18 |
| Device Manufacturer Date | 2018-12-31 |
| Date Added to Maude | 2020-01-16 |
| 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 | 5136448220 |
| 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 | COOLRAIL LINEAR PEN |
| Generic Name | COOLRAIL LINEAR PEN |
| Product Code | OCL |
| Date Received | 2020-01-16 |
| Model Number | MCR1 |
| Catalog Number | A000625 |
| Lot Number | 91616 |
| 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 | 2020-01-16 |