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 2019-01-10 for CRYOICE CRYOSPHERE PROBE A001009 manufactured by Atricure, Inc..
[133227314]
(b)(4) the cryos device was discarded but a device history review for lot number mfr1012a was able to be obtained. After reviewing the mfr1012a for the cryo device, no irregularities associated to the reported failure mode, or possible associated components. There was nothing in the device history record that would indicate the unit was released with any non-conformities that would have contributed to the complaint.
Patient Sequence No: 1, Text Type: N, H10
[133227315]
It was reported that on (b)(6) 2018 a (b)(6) male patient underwent a redo nuss procedure with cryo nerve block. Per the surgeon, while doing cryoa on the left side incision with the cryos device, the braided insulated portion of probe failed to prevent the skin at incision site from being frozen solid. The surgeon excised the frozen portion of the skin to help prevent against frostbite. Procedure was completed. Post procedure the patient pain is being managed by standard nuss protocol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2019-00003 |
| MDR Report Key | 8237727 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-10 |
| Date of Report | 2019-01-10 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2018-12-12 |
| Device Manufacturer Date | 2018-11-06 |
| Date Added to Maude | 2019-01-10 |
| 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. JOHN EHLERT |
| Manufacturer Street | 7555 INNOVATION WAY |
| Manufacturer City | MASON OH 45040 |
| Manufacturer Country | US |
| Manufacturer Postal | 45040 |
| Manufacturer Phone | 5137554563 |
| 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 CRYOSPHERE PROBE |
| Generic Name | CRYOICE CRYOSPHERE PROBE |
| Product Code | GXH |
| Date Received | 2019-01-10 |
| Model Number | CRYOS |
| Catalog Number | A001009 |
| Lot Number | MFR1012A |
| Device Expiration Date | 2019-10-01 |
| Operator | HEALTH 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 | 2019-01-10 |