MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-05-29 for CRYOICE CRYO-ABLATION PROBE CRYO2 A000683-JP manufactured by Atricure, Inc..
[109424662]
(b)(4). The device was not returned for evaluation; however, the device history review was reviewed for lot number 70820 and no non-conformance or reworks were noted during the manufacturing process that relate to the reported issue.
Patient Sequence No: 1, Text Type: N, H10
[109424663]
A (b)(6) year-old-female patient underwent a full maze procedure prior to (b)(6) 2017. There were no reported procedural complications, post procedure, the patient was implanted with a pacemaker. The surgeon indicated the possibility that when he ablated svc line, he also ablated sinus node. The surgeon stated that the width of ablation effective area was wider than a probe, so the ablation might have had some influence on the sinus node. The patient is in stable condition. There were no reported device malfunctions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00167 |
| MDR Report Key | 7549940 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-05-29 |
| Date of Report | 2018-05-29 |
| Date Mfgr Received | 2018-05-09 |
| Device Manufacturer Date | 2017-01-23 |
| Date Added to Maude | 2018-05-29 |
| 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 | 2018-05-29 |
| Model Number | CRYO2 |
| Catalog Number | A000683-JP |
| Lot Number | 70820 |
| Device Expiration Date | 2020-01-01 |
| 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. Required No Informationntervention | 2018-05-29 |