Brand Name | NANOCROSS 0.14 OTW PTA DILATATION CATHETER |
Type of Device | CATHETER, PERCUTANEOUS |
Manufacturer (Section D) |
COVIDIEN |
4600 nathan lane north |
plymouth MN 55442 |
|
Manufacturer (Section G) |
COVIDIEN |
4600 nathan lane north |
|
plymouth MN 55442 |
|
Manufacturer Contact |
mary
haufek
|
4600 nathan lane north |
plymouth, MN 55442
|
7633987000
|
|
MDR Report Key | 5322039 |
MDR Text Key | 35012749 |
Report Number | 2183870-2015-07609 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K090849 |
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 |
05/22/2013 |
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 | 03/31/2014 |
Device Model Number | AB14W020020150 |
Device Catalogue Number | AB14W020020150 |
Device Lot Number | 9543814 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/06/2013 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/22/2013 |
Initial Date FDA Received | 12/23/2015 |
Date Device Manufactured | 02/06/2012 |
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 |