MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-05-21 for CRYOICE CRYO-ABLATION PROBE CRYO2 A000683-JP manufactured by Atricure, Inc..
[108754056]
(b)(4). The device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number was not reported. There were no reported device malfunctions.
Patient Sequence No: 1, Text Type: N, H10
[108754057]
On (b)(6) 2017, a patient underwent a mics/mvp/maze procedure from the endocardium side. At the time, the patient was being weaned from the ventilator, bleeding was noted from the laa and a decision was made to convert the procedure to a sternotomy. The bleeding had occurred while the surgeon was doing the cryoablation from the laa to the left superior pulmonary vein. The surgeon recognized that the bleeding was a technical error by sticking the laa with the cyro2. The laa was repaired and did not necessitate a transfusion. It was reported that there were no device malfunctions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00163 |
| MDR Report Key | 7529668 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-18 |
| Date of Event | 2017-11-10 |
| Date Mfgr Received | 2018-05-07 |
| Date Added to Maude | 2018-05-21 |
| 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 | 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 | 2018-05-21 |
| Model Number | CRYO2 |
| Catalog Number | A000683-JP |
| 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. Life Threatening; 2. Required No Informationntervention | 2018-05-21 |