Brand Name | PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 7F |
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 | 14804305 |
MDR Text Key | 294882445 |
Report Number | 3005334138-2022-00371 |
Device Sequence Number | 1 |
Product Code |
DYB
|
UDI-Device Identifier | 05415067040879 |
UDI-Public | 05415067040879 |
Combination Product (y/n) | N |
Reporter Country Code | CO |
PMA/PMN Number | K894431 |
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 |
07/05/2022 |
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 | 405108 |
Device Catalogue Number | 405108 |
Device Lot Number | 8423242 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
06/17/2022 |
Initial Date FDA Received | 06/24/2022 |
Supplement Dates Manufacturer Received | 06/30/2022
|
Supplement Dates FDA Received | 07/05/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/08/2022 |
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) |
Life Threatening;
|
|
|