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 2018-10-08 for CRYOICE CRYO-ABLATION PROBE CRYO2 A000683 manufactured by Atricure, Inc..
[123059930]
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 for the cryo2 device was not reported or able to be subsequently ascertained. The complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[123059931]
It was reported that on (b)(6) 2018 a (b)(6) female patient underwent an atrial septal defect repair (asd) and was enrolled into the (b)(6) clinical study. The intercostal cryoanalgesia procedure was performed per protocol. The patient complained of hyperesthesia that began on (b)(6) 2018. During the 90-day post procedure follow-up visit it was determined that the patient did not require an in-office pain sensitivity assessment. At the 180 days follow up visit on (b)(6) 2018, the patient still complained about having pain sensitivity in the area around the surgical incision site. This event is a procedure related complication. There was no reported device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00212 |
| MDR Report Key | 7943496 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-08 |
| Date of Report | 2018-10-08 |
| Date of Event | 2018-04-15 |
| Date Mfgr Received | 2018-09-24 |
| Date Added to Maude | 2018-10-08 |
| 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 | 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 CRYO-ABLATION PROBE |
| Generic Name | CRYOICE CRYO-ABLATION PROBE |
| Product Code | GXH |
| Date Received | 2018-10-08 |
| Model Number | CRYO2 |
| Catalog Number | A000683 |
| Lot Number | UNKNOWN |
| 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. Deathisabilit | 2018-10-08 |