Brand Name | TURNPIKE SPIRAL |
Type of Device | CATHETER |
Manufacturer (Section D) |
VASCULAR SOLUTIONS, LLC |
6464 sycamore court north |
minneapolis, mn |
|
Manufacturer (Section G) |
VASCULAR SOLUTIONS, LLC |
6464 sycamore court north |
|
minneapolis, mn |
|
Manufacturer Contact |
mary
haufek
|
6464 sycamore court north |
minneapolis, mn
|
6564230
|
|
MDR Report Key | 10195281 |
MDR Text Key | 199503517 |
Report Number | 2134812-2020-00038 |
Device Sequence Number | 1 |
Product Code |
DQY
|
UDI-Device Identifier | 30841156100708 |
UDI-Public | (01)30841156100708 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K191560 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
consumer,health professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/04/2020 |
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 Model Number | 5640 |
Device Lot Number | 653274 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/04/2020 |
Initial Date FDA Received | 06/25/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/24/2019 |
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 | 88 YR |
|
|