Brand Name | FARADRIVE STEERABLE SHEATH CLEAR |
Type of Device | VASCULAR GUIDE-CATHETER, SINGLE-USE |
Manufacturer (Section D) |
FARAPULSE, INC. |
3715 haven avenue |
suite 110 |
menlo park CA 94025 |
|
Manufacturer (Section G) |
CENTERPOINT SYSTEMS |
3338 parkway blvd |
|
west valley city UT 84119 |
|
Manufacturer Contact |
timothy
degroot
|
4100 hamline avenue north |
dc a330 |
saint paul, MN 55112
|
6515826168
|
|
MDR Report Key | 19152544 |
MDR Text Key | 341123895 |
Report Number | 2124215-2024-22773 |
Device Sequence Number | 1 |
Product Code |
QZI
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/22/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Lot Number | CL12232 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/25/2024
|
Initial Date FDA Received | 04/22/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/16/2023 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |