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 2017-07-20 for ATRICURE CRYO MODULE SYSTEM CRYOICE CRYO-ABLATION PROBE A000683 manufactured by Atricure, Inc..
[80546183]
(b)(4) there was no device malfunction reported, all devices functioned as expected. The device was not returned for evaluation and no device history review was done as no lot number was provided.
Patient Sequence No: 1, Text Type: N, H10
[80546184]
A (b)(6) male had an initial procedure of a cabg/maze which was completed on (b)(6) 2017. There were no complications during the procedure and no equipment malfunctions reported. The patient was on-pump and heparinized with an act of >440. Post-op course of care was uncomplicated. Patients medical history consisted of barrett? S esophagus, cad, and a fib. The patient present to the hospital emergency department on (b)(6) 2017 with hematemesis. Over the next 12 hours, the patient was in shock, intubated, and in renal failure. Ct surgery was notified and at that time, the family refused intervention to correct the diagnosis of aef. The patient expired on (b)(6) 2017 and the surgeon that did the initial procedure believes that the barrett? S esophagus contributed to the aef. No autopsy was done. Based on reported information, no reportable device malfunction occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2017-00064 |
| MDR Report Key | 6728281 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-20 |
| Date of Report | 2017-07-20 |
| Date of Event | 2017-06-23 |
| Date Mfgr Received | 2017-06-26 |
| Date Added to Maude | 2017-07-20 |
| 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 | 2017-07-20 |
| Model Number | CRYOICE CRYO-ABLATION PROBE |
| Catalog Number | A000683 |
| 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. Death; 2. Life Threatening | 2017-07-20 |