Brand Name | MEDTRONIC |
Type of Device | HAWK ONE DIRECTIONAL ATHERECTOMY SYSTEM |
Manufacturer (Section D) |
MEDTRONIC, INC. |
710 medtronic pkwy |
minneapolis MN 55432 |
|
MDR Report Key | 9397117 |
MDR Text Key | 169018724 |
Report Number | 9397117 |
Device Sequence Number | 1 |
Product Code |
MCW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
11/27/2019 |
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 Expiration Date | 02/19/2022 |
Device Catalogue Number | HI-14550 |
Device Lot Number | 0009603207 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 11/27/2019 |
Distributor Facility Aware Date | 11/26/2019 |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 12/02/2019 |
Was Device Evaluated by Manufacturer? |
No Information
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 79 YR |
Patient Weight | 95 |
|
|