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 2018-07-18 for CRYOICE CRYO-ABLATION PROBE CRYO2 A000683 manufactured by Atricure, Inc..
[114319638]
Case: (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 was no reported device malfunction.
Patient Sequence No: 1, Text Type: N, H10
[114319639]
On (b)(6) 2018 it was reported that a review of 29 - nuss procedures completed by 6 different surgeons was done. The review of cases by the practice showed that of the 29 cases done within the last 6 months, 6 patients had confirmed pneumothorax and one of those 6 patients sustained a lung injury that extended the hospital stay by 2 days. Further information was that all patients fully recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00189 |
| MDR Report Key | 7698269 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-18 |
| Date of Report | 2018-07-17 |
| Date Mfgr Received | 2018-07-06 |
| Date Added to Maude | 2018-07-18 |
| 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 | MR. SCOTT EHLERT |
| 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 | 2018-07-18 |
| Model Number | CRYO2 |
| Catalog Number | A000683 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-07-18 |