Brand Name | AGILIS EPI STEERABLE INTRODUCER DUAL-REACH 40 CM SHEATH, SMALL CURL, 8.5F |
Type of Device | INTRODUCER, CATHETER |
Manufacturer (Section D) |
ST. JUDE MEDICAL |
5050 nathan lane north |
plymouth MN 55442 |
|
MDR Report Key | 10733640 |
MDR Text Key | 213010644 |
Report Number | 3005334138-2020-00533 |
Device Sequence Number | 1 |
Product Code |
DYB
|
Combination Product (y/n) | N |
PMA/PMN Number | K061363 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Type of Report
| Initial,Followup,Followup |
Report Date |
11/18/2020 |
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? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/31/2022 |
Device Model Number | G408333 |
Device Lot Number | 6935408 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
10/15/2020 |
Initial Date FDA Received | 10/26/2020 |
Supplement Dates Manufacturer Received | 11/05/2020 11/05/2020
|
Supplement Dates FDA Received | 11/12/2020 11/18/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | ADVISOR HD GRID MAPPING CATHETER, SE; TACTICATH ABLATION CATHETER, SE; ADVISOR HD GRID MAPPING CATHETER, SE; TACTICATH ABLATION CATHETER, SE |
|
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