Brand Name | ULTRAVERSE RX PTA DILATATION CATHETER |
Type of Device | PTA BALLOON DILATATION CATHETER |
Manufacturer (Section D) |
BARD PERIPHERAL VASCULAR, INC. |
1625 w 3rd st. |
tempe AZ 85281 |
|
Manufacturer (Section G) |
CLEARSTREAM TECHNOLOGIES LTD. |
moyne upper |
|
enniscorthy, co. wexford N A |
EI
N A
|
|
Manufacturer Contact |
judy
ludwig
|
800 w. rio salado pkwy |
tempe, AZ 85281
|
4803032689
|
|
MDR Report Key | 10893549 |
MDR Text Key | 217940424 |
Report Number | 2020394-2020-20572 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (Y/N) | N |
Reporter Country Code | US |
PMA/PMN Number | K131199 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,HEALTH |
Reporter Occupation |
|
Type of Report
| Initial |
Report Date |
10/30/2020 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 11/24/2020 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | U4200215RX |
Device Catalogue Number | U4200215RX |
Device LOT Number | CMCU0484 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 10/28/2020 |
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
|