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 2018-02-26 for CRYOICE CRYO-ABLATION PROBE CRYO2 A000683 manufactured by Atricure, Inc..
[100897609]
(b)(4) the device was not returned for evaluation and a device history review was unable to be completed as the relevant cryo2 lot number was not reported or able to be subsequently ascertained. There was no reported device malfunction or procedure complication.
Patient Sequence No: 1, Text Type: N, H10
[100897610]
On 1/29/2018 during a conversation between the sales rep and a surgeon, the surgeon stated that a patient reported abdominal bulging showing up shortly following a vats lobectomy procedure with cryoa where the cryo2 cryo-ablation probe was used. The patient reported the adverse event during the 30 day follow up visit and the surgeon noted an asymmetry of the abdominal wall on the side in which he cryoablated with the cryo2 device. It first presented as abdominal muscle bulging which he thought would recover following nerve regeneration, by the next follow up visit which was at 12 months, it was noted that the abdominal wall did not recover. He thought it was coming from cryoablating levels 9, 10, and 11. He has now resorted to cryoablating above the 9th intercostal spaces only. The current condition of the patient is persistent muscle bulging of the abdominal wall on cryoablation side of chest wall following lung surgery. It was reported that this was not a painful complaint and did not necessitate any type of pain treatment, it was more of a cosmetic complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011706110-2018-00129 |
| MDR Report Key | 7295678 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-26 |
| Date Mfgr Received | 2018-01-29 |
| Date Added to Maude | 2018-02-26 |
| 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 | 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 | 2018-02-26 |
| Model Number | CRYO2 |
| Catalog Number | A000683 |
| Lot Number | UNKNOWN |
| Operator | OTHER HEALTH CARE 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 | 2018-02-26 |