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 ATRICURE CRYO PEN (UNKNOWN) UNKNOWN manufactured by Atricure, Inc..
[123066047]
(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 cryo device was not reported or able to be subsequently ascertained.
Patient Sequence No: 1, Text Type: N, H10
[123066048]
Surgeon reported that he was having an issue with a patient he used cryo device in (b)(6) 2018, for a surgical procedure for broken ribs where he had to plate the ribs back together. The surgeon resected the bottom lip of the rib, exposed the neurovascular bundle and froze levels 7-10 nerve externally, at least 6cm away from the transverse process laterally under each rib for pain management. Two months post-procedure patient has a bulge posterolateral, lower flank, consistent with lower thoracoabdominal wall denervation. Patient is undergoing physiotherapy. This event is a procedure related complication. Atricure does not recommend ablation below the 9th intercostal space per cryoanalgesia procedural guide (b)(4). There was no reported device malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00213 |
| MDR Report Key | 7944689 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-08 |
| Date of Report | 2018-10-08 |
| 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 | ATRICURE CRYO PEN (UNKNOWN) |
| Catalog 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 |