Brand Name | CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER |
Type of Device | CATHETER, PERCUTANEOUS |
Manufacturer (Section D) |
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
15900 valley view court |
sylmar CA 91342 |
|
Manufacturer (Section G) |
ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
15900 valley view court |
|
sylmar CA 91342 |
|
Manufacturer Contact |
elizabeth
boltz
|
15900 valley view court |
sylmar, CA 91342
|
|
MDR Report Key | 9775782 |
MDR Text Key | 181735890 |
Report Number | 2017865-2020-02884 |
Device Sequence Number | 1 |
Product Code |
DQY
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130257 |
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 |
03/02/2020 |
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 Model Number | DS2C020/135 |
Device Lot Number | 7228969 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
02/24/2020 |
Initial Date FDA Received | 03/02/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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;
|
Patient Age | 84 YR |
|
|