Brand Name | BRAIDED SWARTZ¿ INTRODUCER, SL0¿. 8F, 63CM |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
ST. JUDE MEDICAL H) |
5050 nathan lane north |
plymouth MN 55442 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL |
5050 nathan lane north |
|
plymouth MN 55442 |
|
Manufacturer Contact |
janna
parks
|
5050 nathan lane north |
plymouth, MN 55442
|
6517565400
|
|
MDR Report Key | 14015843 |
MDR Text Key | 289106491 |
Report Number | 3005334138-2022-00277 |
Device Sequence Number | 1 |
Product Code |
DYB
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K052644 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/13/2022 |
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 | 04/30/2024 |
Device Model Number | G407371 |
Device Lot Number | 7963070 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
04/01/2022 |
Initial Date FDA Received | 04/05/2022 |
Supplement Dates Manufacturer Received | 04/13/2022
|
Supplement Dates FDA Received | 04/13/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/10/2021 |
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 |
|
|