Brand Name | IMPRESS ANGIOGRAPHIC CATHETER |
Type of Device | ANGIOGRAPHIC CATHETER |
Manufacturer (Section D) |
MERIT MEDICAL SYSTEMS, INC |
14646 kirby drive |
houston TX 77047 |
|
Manufacturer (Section G) |
MERIT MEDICAL SYSTEMS, INC |
14646 kirby drive |
|
houston TX 77047 |
|
Manufacturer Contact |
casey
hughes, ms, cqe
|
1600 west merit parkway |
south jordan, UT 84095
|
8013164932
|
|
MDR Report Key | 5921307 |
MDR Text Key | 53711252 |
Report Number | 3010665433-2016-00056 |
Device Sequence Number | 1 |
Product Code |
DQO
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K053171 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
08/08/2016 |
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 | 06/30/2019 |
Device Catalogue Number | 56538VER |
Device Lot Number | E974247 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/30/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
08/08/2016
|
Initial Date FDA Received | 09/01/2016 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/22/2016
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/15/2016 |
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 |
|
|