MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-06-29 for CRYOICE CRYO-ABLATION PROBE CRYO2 A000683-JP manufactured by Atricure, Inc..
[112745606]
(b)(4) the device with lot #80608 was returned for evaluation. Complaint is confirmed, upon evaluation the mylar was torn. Device will be scrapped out of inventory per the established procedure. The device was returned from a distributor, not a facility, no patient involvement.
Patient Sequence No: 1, Text Type: N, H10
[112745607]
It was reported on (b)(6) 2018 by the 3rd party distributor that the last shipment they had received, there were two cryo2 devices that failed their incoming inspection for vacuum pack error. The packaging was torn which compromised the sterility of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00177 |
| MDR Report Key | 7650795 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-06-29 |
| Date of Report | 2018-06-29 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2018-01-30 |
| Date Added to Maude | 2018-06-29 |
| 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 |
| 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 | 2018-06-29 |
| Returned To Mfg | 2018-06-22 |
| Model Number | CRYO2 |
| Catalog Number | A000683-JP |
| Lot Number | 80608 |
| Device Availability | R |
| 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 | 2018-06-29 |