Brand Name | ATRIUM ICAST COVERED STENT |
Type of Device | PTFE COVERED STENT |
Manufacturer (Section D) |
ATRIUM MEDICAL CORPORATION |
5 wentworth drive |
hudson NH 03051 |
|
Manufacturer (Section G) |
ATRIUM MEDICAL CORPORATION |
5 wentworth drive |
|
hudson NH 03051 |
|
Manufacturer Contact |
lynda
mclaughlin rn, bsn,ccrn-k
|
40 continental blvd |
merrimack, NH 03054
|
6038645470
|
|
MDR Report Key | 6464684 |
MDR Text Key | 71906861 |
Report Number | 1219977-2017-00049 |
Device Sequence Number | 1 |
Product Code |
JCT
|
UDI-Device Identifier | 00650862854190 |
UDI-Public | 00650862854190 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K050814 |
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,Followup |
Report Date |
04/04/2017 |
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 |
Physician
|
Device Expiration Date | 12/09/2019 |
Device Model Number | 85419 |
Device Catalogue Number | 85419 |
Device Lot Number | 244943 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/13/2017 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/01/2017
|
Initial Date FDA Received | 04/06/2017 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/03/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 12/09/2016 |
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 | C2 COOK SELECTION CATHETER; ROSEN GUIDEWIRE 0.035 X 260 CM; SPECTRANETICS QUICK CROSS EXCHANGE WIRE; TERUMO DESTINATION 7FR X 90 CM SHEATH |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 68 YR |