Brand Name | CARDIOBLATE SURGICAL ABLATION XL PEN |
Type of Device | SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE |
Manufacturer (Section D) |
PERFUSION SYSTEMS |
7611 northland dr |
brooklyn park MN 55428 |
|
Manufacturer (Section G) |
PERFUSION SYSTEMS |
7611 northland dr |
|
brooklyn park MN 55428 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea street ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 10568235 |
MDR Text Key | 207975520 |
Report Number | 2184009-2020-00057 |
Device Sequence Number | 1 |
Product Code |
OCL
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K031247 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,s |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
09/22/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 60814 |
Device Catalogue Number | 60814 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
08/24/2020
|
Initial Date FDA Received | 09/22/2020 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|