Brand Name | NC TREK CORONARY DILATATION CATHETER |
Type of Device | CORONARY DILATATION CATHETER |
Manufacturer (Section D) |
ABBOTT VASCULAR |
26531 ynez rd. |
temecula CA 92591 4628 |
|
Manufacturer (Section G) |
ABBOTT VASCULAR COSTA RICA, REG # 3009564766 |
52 calle 3 b31 coyol free zone |
|
el coyol alajuela |
CS
|
|
Manufacturer Contact |
lindsey
bell
|
26531 ynez rd. |
temecula, CA 92591-4628
|
9519143996
|
|
MDR Report Key | 13043115 |
MDR Text Key | 284981134 |
Report Number | 2024168-2021-11860 |
Device Sequence Number | 1 |
Product Code |
LOX
|
UDI-Device Identifier | 08717648151811 |
UDI-Public | 08717648151811 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K103153 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/20/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/20/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 10/31/2023 |
Device Model Number | 1012448-12 |
Device Catalogue Number | 1012448-12 |
Device Lot Number | 01103G1 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/29/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/03/2020 |
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 |
Patient Age | 68 YR |
Patient Sex | Male |
Patient Weight | 71 KG |