Brand Name | ADVANCE 14 LP LOW PROFILE BALLOON CATHETER |
Type of Device | DQY CATHETER, PERCUTANEOUS |
Manufacturer (Section D) |
COOK INC |
750 daniels way |
bloomington IN 47404 |
|
Manufacturer Contact |
larry
pool
|
750 daniels way |
bloomington, IN 47404
|
8128294891
|
|
MDR Report Key | 7593458 |
MDR Text Key | 111326003 |
Report Number | 1820334-2018-01755 |
Device Sequence Number | 1 |
Product Code |
DQY
|
UDI-Device Identifier | 10827002503172 |
UDI-Public | (01)10827002503172(17)171218(10)5527993 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,health professional,o |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
06/12/2018 |
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 Catalogue Number | PTAX4-14-170-2-12 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/06/2018 |
Initial Date FDA Received | 06/12/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/18/2014 |
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 |