MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-26 for ATRICURE CRYOBLATION PROBE 10 CM CRY03 manufactured by Atricure Inc..
[181631679]
When the surgeon went to freeze a section of the pt's heart, the probe fractured and froze a larger area of the heart than anticipated. The pt was not injured, as the heart thawed before the probe was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093325 |
| MDR Report Key | 9763723 |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-24 |
| Date Added to Maude | 2020-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATRICURE CRYOBLATION PROBE |
| Generic Name | UNIT, CRYOSURGICAL, ACCESSORIES |
| Product Code | GEH |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2020-01-24 |
| Model Number | 10 CM |
| Catalog Number | CRY03 |
| Lot Number | 95189 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRICURE INC. |
| Manufacturer Address | MASON OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |