Brand Name | CPS AIM SL SUBSELECTOR, SUB-ACU VALVE |
Type of Device | CATHETER |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC. |
15900 valley view court |
sylmar CA 91342 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC. |
15900 valley view court |
|
sylmar CA 91342 |
|
Manufacturer Contact |
robert
greenleaf
|
15900 valley view court |
sylmar, CA 91342
|
8184932577
|
|
MDR Report Key | 7021166 |
MDR Text Key | 92211669 |
Report Number | 2017865-2017-34427 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
Reporter Country Code | UK |
PMA/PMN Number | K090613 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/10/2017 |
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 | 02/28/2019 |
Device Model Number | DS2N021-59 |
Device Lot Number | 5430986 |
Other Device ID Number | 05414734218023 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/16/2017 |
Initial Date FDA Received | 11/10/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/18/2016 |
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 |
|
|