Brand Name | TURNPIKE CATHETER |
Type of Device | CATHETER |
Manufacturer (Section D) |
VASCULAR SOLUTIONS, INC. |
6464 sycamore court north |
maple grove MN 55369 |
|
Manufacturer (Section G) |
VASCULAR SOLUTIONS, INC. |
6464 sycamore court north |
|
maple grove MN 55369 |
|
Manufacturer Contact |
renee
michael
|
6464 sycamore court north |
maple grove, MN 55369
|
7636564366
|
|
MDR Report Key | 5318736 |
MDR Text Key | 34136392 |
Report Number | 2134812-2015-00044 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K142065 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,user f |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
11/24/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Physician
|
Device Expiration Date | 06/30/2017 |
Device Model Number | 5642 |
Device Lot Number | 584725 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/10/2015 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/24/2015 |
Initial Date FDA Received | 12/22/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 04/20/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/06/2015 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|