Brand Name | WEB SL |
Type of Device | INTRASACCULAR DEVICES |
Manufacturer (Section D) |
MICROVENTION, INC. |
35 enterprise |
aliso viejo CA 92868 |
|
Manufacturer Contact |
terrence
callahan
|
35 enterprise |
aliso viejo, CA 92656
|
7142478000
|
|
MDR Report Key | 19060801 |
MDR Text Key | 339607088 |
Report Number | 2032493-2024-00278 |
Device Sequence Number | 1 |
Product Code |
OPR
|
UDI-Device Identifier | 04987892122415 |
UDI-Public | (01)04987892122415(11)221007(17)270930(10)0000269093 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | P170032 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/08/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/08/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | MV-WB080427 |
Device Lot Number | 0000269093 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
No
|
Date Manufacturer Received | 03/18/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/07/2022 |
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 | SOFIA SELECT (5F 125CM).; VIA 17 MICROCATHETER. |
Patient Outcome(s) |
Other;
|