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 2017-09-14 for ATRICURE CRYO MODULE SYSTEM CRYOICE CRYO-ABLATION PROBE A000683 manufactured by Atricure, Inc..
[86118795]
(b)(4) the device was discarded by the facility after procedure as there were no known product problems or issues. No device malfunction was reported during this event.
Patient Sequence No: 1, Text Type: N, H10
[86118796]
A patient had a thoracotomy procedure on (b)(6) 2017 and was treated in the intercostal incision spaces 4? 8 with cryoa for pain management with a 2-minute freeze time of the nerve ending area. The pain management results were good in hospital. There was no fracture of ribs during the procedure and the patient was discharged home as expected. During the four week follow up visit, (b)(6) 2017, the patient presented stating he was in excruciating pain around the rib area and felt very ill. There was never any fever or vomiting. The surgeon prescribed the patient some pain medication and not needed further follow up or treatment at this time. Product performed as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2017-00081 |
| MDR Report Key | 6864642 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-14 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-08-18 |
| Date Mfgr Received | 2017-08-18 |
| Date Added to Maude | 2017-09-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANUPAM BEDI |
| 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 | ATRICURE CRYO MODULE SYSTEM |
| Generic Name | ATRICURE CRYO MODULE SYSTEM |
| Product Code | GXH |
| Date Received | 2017-09-14 |
| Model Number | CRYOICE CRYO-ABLATION PROBE |
| Catalog Number | A000683 |
| Lot Number | UNKNOWN |
| Operator | OTHER HEALTH CARE 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. Other | 2017-09-14 |