Brand Name | DRAGONFLY¿ OPTIS¿ KIT BOX IMAGING CATHETER |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
ST. JUDE MEDICAL CATD |
4 robbins drive |
westford MA 01886 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL CATD |
4 robbins drive |
|
westford MA 01886 |
|
Manufacturer Contact |
stephanie
o' sullivan
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 8358018 |
MDR Text Key | 136752386 |
Report Number | 3009600098-2019-00005 |
Device Sequence Number | 1 |
Product Code |
DQO
|
UDI-Device Identifier | 00183739000654 |
UDI-Public | 00183739000654 |
Combination Product (y/n) | N |
Reporter Country Code | PL |
PMA/PMN Number | K141769 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
02/21/2019 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | C408646 |
Device Catalogue Number | C408646 |
Device Lot Number | 6702621 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/19/2019 |
Initial Date FDA Received | 02/21/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/06/2018 |
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 | 48 YR |