Brand Name | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
Type of Device | PERIPHERAL ATHERECTOMY DEVICE |
Manufacturer (Section D) |
CARDIOVASCULAR SYSTEMS, INC. |
1225 old highway 8 nw |
saint paul, mn |
|
Manufacturer (Section G) |
CARDIOVASCULAR SYSTEMS, INC. |
1225 old highway 8 nw |
|
saint paul, mn |
|
Manufacturer Contact |
sarah
hicks
|
1225 old highway 8 nw |
saint paul, mn
|
|
MDR Report Key | 9948163 |
MDR Text Key | 188340318 |
Report Number | 3004742232-2020-00117 |
Device Sequence Number | 1 |
Product Code |
MCW
|
UDI-Device Identifier | 10852528005718 |
UDI-Public | (01)10852528005718(17)211130(10)297060 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K190634 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/10/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/10/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/30/2021 |
Device Model Number | VPR-GW-FLEX14 |
Device Catalogue Number | 7-10041-03 |
Device Lot Number | 297060 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/27/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/11/2019 |
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;
|
Patient Age | 85 YR |