Brand Name | NANOCROSS 0.14 OTW PTA DILATATION CATHETER |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
COVIDIEN |
4600 nathan lane north |
plymouth MN 55442 |
|
Manufacturer (Section G) |
COVIDIEN |
4600 nathan lane north |
|
plymouth MN 55442 |
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
091708734
|
|
MDR Report Key | 6386730 |
MDR Text Key | 69325846 |
Report Number | 2183870-2017-00115 |
Device Sequence Number | 1 |
Product Code |
LIT
|
UDI-Device Identifier | 00821684066522 |
UDI-Public | 00821684066522 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132777 |
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 |
02/07/2017 |
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 | 01/06/2020 |
Device Model Number | AB14W030210150 |
Device Lot Number | A396829 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/07/2017 |
Initial Date FDA Received | 03/08/2017 |
Supplement Dates Manufacturer Received | 02/07/2017
|
Supplement Dates FDA Received | 10/02/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 01/06/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 95 YR |
Patient Weight | 64 |
|
|