Brand Name | FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SWARTZ¿ SL TRANSSEPTAL SERIES, SL1¿ 8. |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
ST. JUDE MEDICAL |
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 | 14874743 |
MDR Text Key | 296139788 |
Report Number | 3005334138-2022-00389 |
Device Sequence Number | 1 |
Product Code |
DYB
|
UDI-Device Identifier | 05414734203388 |
UDI-Public | 05414734203388 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K061015 |
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 |
11/01/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 06/30/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 406849 |
Device Catalogue Number | 406849 |
Device Lot Number | 8199887 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 11/01/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/28/2021 |
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 |
Treatment | BRK¿ TRANSSEPTAL NEEDLE |
|
|