Brand Name | ADVANCE 35 LP LOW PROFILE BALLOON CATHETER |
Type of Device | LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
COOK, INC. |
bloomington IN 47404 |
|
Manufacturer Contact |
rita
harden, director
|
750 daniels way |
bloomington, IN 47404
|
8123392235
|
|
MDR Report Key | 4332028 |
MDR Text Key | 5256485 |
Report Number | 1820334-2014-00627 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K132020 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
11/10/2014 |
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 |
Health Professional
|
Device Expiration Date | 04/01/2017 |
Device Catalogue Number | PTA5-35-135-5-20.0 |
Device Lot Number | 4906847 |
Other Device ID Number | UDI#: (01)10827002355320(17) |
Was Device Available for Evaluation? |
Yes
|
Date Returned to Manufacturer | 12/02/2014 |
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Distributor Facility Aware Date | 11/04/2014 |
Device Age | 7 MO |
Event Location |
Hospital
|
Initial Date Manufacturer Received |
11/10/2014
|
Initial Date FDA Received | 12/05/2014 |
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 04/01/2014 |
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 Outcome(s) |
Required Intervention;
|
|
|