Brand Name | RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER |
Type of Device | PERIPHERAL DILATATION CATHETER |
Manufacturer (Section D) |
AV-TEMECULA-CT |
abbott vascular |
26531 ynez road |
temecula CA 92591 4628 |
|
Manufacturer (Section G) |
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168 |
abbott vascular |
26531 ynez road |
temecula CA 92591 4628 |
|
Manufacturer Contact |
connie
speck
|
abbott vascular |
26531 ynez road |
temecula, CA 92591-4628
|
9519143996
|
|
MDR Report Key | 8033660 |
MDR Text Key | 126300474 |
Report Number | 2024168-2018-08414 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (Y/N) | N |
Reporter Country Code | CH |
PMA/PMN Number | K102705 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,DISTRI |
Reporter Occupation |
|
Remedial Action |
Other |
Type of Report
| Initial,Followup |
Report Date |
11/14/2018 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 11/02/2018 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device EXPIRATION Date | 07/31/2020 |
Device Catalogue Number | 1008193-30 |
Device LOT Number | 8081061 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 11/07/2018 |
Is The Reporter A Health Professional? |
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 11/08/2018 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 08/01/2018 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|