Brand Name | DIRECTIONAL ATHERECTOMY SYSTEM WITH CATHETER LARGE VESSEL STANDARD TIP |
Type of Device | CATHETER, PERIPHERAL, ATHERECTOMY |
Manufacturer (Section D) |
MEDTRONIC, INC. |
minneapolis MN 55432 |
|
MDR Report Key | 8270873 |
MDR Text Key | 134006049 |
Report Number | MW5083297 |
Device Sequence Number | 0 |
Product Code |
MCW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
01/18/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/21/2021 |
Device Model Number | REF H1-14550 |
Device Catalogue Number | H1-LS |
Device Lot Number | 0009340612 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/18/2019 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 01/22/2019 |
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 Outcome(s) |
Required Intervention;
|
Patient Age | 67 YR |
|
|