Brand Name | STEALTH 360 ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE GUIDE WIRE) |
Type of Device | PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE) |
Manufacturer (Section D) |
CARDIOVASCULAR SYSTEMS, INC. |
1225 old hwy 8 nw |
st. paul MN 55112 |
|
Manufacturer (Section G) |
CARDIOVASCULAR SYSTEMS, INC. |
1225 old hwy 8 nw |
|
st. paul MN 55112 |
|
Manufacturer Contact |
tonia
moskalets
|
1225 old hwy 8 nw |
st. paul, MN 55112
|
|
MDR Report Key | 16326281 |
MDR Text Key | 309072150 |
Report Number | 3004742322-2023-00036 |
Device Sequence Number | 1 |
Product Code |
MCW
|
UDI-Device Identifier | 10850000491165 |
UDI-Public | (01)10850000491165(17)240131(10)424017-2 |
Combination Product (y/n) | N |
Reporter Country Code | FI |
PMA/PMN Number | K190634 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/08/2023 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2024 |
Device Model Number | VPR-GW-17 |
Device Lot Number | 424017-2 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/12/2023
|
Initial Date FDA Received | 02/08/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/28/2022 |
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 |
Treatment | STEALTH 360 ORBITAL ATHERECTOMY DEVICE |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 84 YR |
Patient Sex | Female |