Brand Name | ANGIOSCULPT EVO RX PTCA SCORING BALLOON CATHETER WITH HYDROPHILIC COATING |
Type of Device | CATHETER, PTCA, CUTTING/SCORING |
Manufacturer (Section D) |
PHILIPS IMAGE GUIDED THERAPY CORPORATION |
5055 brandin court |
fremont CA 94538 |
|
Manufacturer (Section G) |
PHILIPS IMAGE GUIDED THERAPY CORPORATION |
5055 brandin court |
|
fremont CA 94538 |
|
Manufacturer Contact |
diana melliza
galvez
|
5055 brandin court |
fremont, CA 94538
|
510933-454
|
|
MDR Report Key | 18954162 |
MDR Text Key | 338309260 |
Report Number | 3005462046-2024-00009 |
Device Sequence Number | 1 |
Product Code |
NWX
|
UDI-Device Identifier | 00813132026912 |
UDI-Public | (01)00813132026912(11)230223(17)260223(10)G23020033 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P050018 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/21/2024 |
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 | 2200-3506-B |
Device Catalogue Number | 2200-3506-B |
Device Lot Number | G23020033 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 03/21/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 02/23/2023 |
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 |
Treatment | MEDTRONIC: 7F EBU 3.5 GUIDE CATHETER; TERUMO: 0.014" RUNTHROUGH GUIDEWIRE; TERUMO: 7F SLENDER INTRODUCER SHEATH |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
|
Patient Sex | Female |
Patient Ethnicity | Non Hispanic |
Patient Race | White |