Brand Name | TACK ENDOVASCULAR SYSTEM (4F, 1.5 - 4.5MM) |
Type of Device | TACK ENDOVASCULAR SYSTEM (4F, 1.4 - 4.5MM) |
Manufacturer (Section D) |
INTACT VASCULAR, INC. |
1285 drummers lane |
suite #200 |
wayne PA 19087 |
|
Manufacturer (Section G) |
INTACT VASCULAR, INC. |
1285 drummers lane |
suite #200 |
wayne PA 19087 |
|
Manufacturer Contact |
kimberly
mcgill
|
1285 drummers lane |
suite #200 |
wayne, PA 19087
|
4842531048
|
|
MDR Report Key | 12031330 |
MDR Text Key | 257162619 |
Report Number | 3012608866-2021-00002 |
Device Sequence Number | 1 |
Product Code |
QCT
|
UDI-Device Identifier | 00863328000196 |
UDI-Public | 0863328000196 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P180034 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
05/24/2021 |
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 | 08/13/2022 |
Device Catalogue Number | 154150041 |
Device Lot Number | 240008 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/21/2021
|
Initial Date FDA Received | 06/21/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/13/2020 |
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 | 0.035 GUIDEWIRE / GLIDEWIRE; 2MM LASER CATHETER; 4MM SPIDER FILTER WIRE; 4X40MM BALLOON; 4X80MM BALLOON; 5F OMNI FLUSH CATHETER; 5F SHEATH; 5X220MM BALLOON; 6F MYNX VASCULAR CLSOURE DEVICE; 6F SHORT SHEATH; BERENSTEIN 6F SHEATH; IVUS |