Brand Name | FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM |
Type of Device | CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER |
Manufacturer (Section D) |
FARAPULSE, INC. |
3715 haven avenue |
suite 110 |
menlo park CA 94025 |
|
Manufacturer (Section G) |
AGILE MV INC |
3700 st patrick st suite 102 |
|
montreal, qc H4E 1 A2 |
CA
H4E 1A2
|
|
Manufacturer Contact |
timothy
degroot
|
4100 hamline avenue north |
dc a330 |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 18966121 |
MDR Text Key | 338434883 |
Report Number | 2124215-2024-17611 |
Device Sequence Number | 1 |
Product Code |
QZI
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Study,Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/22/2024 |
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 Lot Number | 0008021560 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/01/2024
|
Initial Date FDA Received | 03/23/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/18/2023 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 68 YR |
Patient Sex | Male |
Patient Weight | 68 KG |