MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-03-09 for CRYOICE CRYO-ABLATION PROBE A000683-JP manufactured by Atricure, Inc..
[102332652]
(b)(4) the device was returned for evaluation and was visually and functionally tested. Upon evaluation of device, it was discovered what the customer described at scratches was actually torn mylar which exposes the product. An investigation has been initiated.
Patient Sequence No: 1, Text Type: N, H10
[102332653]
On (b)(6) 2018, it was reported by the distributor that a cryoice cryoablation probe (cryo2) failed incoming inspection for a scratch on the product. This was identified upon receipt by the customer. On 2/9/2018, when the device had been returned for evaluation, it was determined that the sterile packaging was torn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00134 |
| MDR Report Key | 7328762 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-03-09 |
| Date of Report | 2018-03-09 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2017-01-24 |
| Date Added to Maude | 2018-03-09 |
| 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 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 | 2018-03-09 |
| Returned To Mfg | 2018-02-02 |
| Model Number | CRYOICE CRYO-ABLATION PROBE |
| Catalog Number | A000683-JP |
| Lot Number | 70821 |
| Device Expiration Date | 2019-10-01 |
| 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 | 2018-03-09 |