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 2018-04-27 for CRYOICE CRYO-ABLATION PROBE CRYO2 A000683 manufactured by Atricure, Inc..
[106835830]
(b)(4). The device was not returned for evaluation; however, the product history review was unable to be completed as the relevant device lot/serial number was not reported or able to be subsequently ascertained.
Patient Sequence No: 1, Text Type: N, H10
[106835931]
On (b)(6) 2017, a male patient underwent a surgical procedure where cryoanalgesia was used for treatment in pain management. When the patient was seen in follow up 3 months later, he reported not sweating on his left side which was persistent for the 3-month period. The surgeon reported freezing the 2nd and 3rd intercostal spaces, even though it is not recommended. There were no other reported side effects from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00150 |
| MDR Report Key | 7470577 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-04-27 |
| Date of Report | 2018-04-27 |
| Date of Event | 2017-12-20 |
| Date Mfgr Received | 2018-03-30 |
| Date Added to Maude | 2018-04-27 |
| 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 Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| 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 | CRYOICE CRYO-ABLATION PROBE |
| Generic Name | CRYOICE CRYO-ABLATION PROBE |
| Product Code | GXH |
| Date Received | 2018-04-27 |
| Model Number | CRYO2 |
| 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. Deathisabilit | 2018-04-27 |