MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2020-01-08 for CRYO CONSOLE 65CS1-002R CONSOLE manufactured by Medtronic, Inc..
[179946858]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[179946859]
The patient had a concomitant surgical procedure of aortic valve replacement, mitral valve replacement through sternotomy. During the same procedure ((b)(6) 2019) a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a cardioblate generator were used. The left atrial appendage was successfully amputated/excised, sutured closed. Left pulmonary vein (pv) and right pulmonary vein (pv) conduction block was not achieved as patient was in atrial fibrillation. On the next day after the procedure ((b)(6) 2019) the patient experienced post-operative bleeding which was treated with a blood transfusion and the patient was given sodium bicarbonate, calcium chloride, epinephrine and re-intubated. Event was resolved (b)(6) 2019. The adverse event was deemed by the site as probably related to the concomitant procedure but not related to the study devices or the study procedure. The clinical events committee (cec) deemed a causal relationship between the concomitant procedure, study procedure, cryoflex probe, cryoconsole, cardioblate clamp and cardioblate generator to the adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008592544-2020-00002 |
| MDR Report Key | 9562334 |
| Report Source | STUDY |
| Date Received | 2020-01-08 |
| Date of Report | 2020-02-28 |
| Date of Event | 2019-10-30 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-01-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | 3800 ANNAPOLIS LANE |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRYO CONSOLE 65CS1-002R CONSOLE |
| Generic Name | SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE |
| Product Code | OCL |
| Date Received | 2020-01-08 |
| Model Number | 65CS1-002R |
| Catalog Number | 65CS1-002R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 3800 ANNAPOLIS LANE MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-08 |