Brand Name | INTERLOCK |
Type of Device | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORK LIMITED |
model farm road |
|
cork |
EI
|
|
Manufacturer Contact |
jay
johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 12743860 |
MDR Text Key | 279786913 |
Report Number | 2134265-2021-13693 |
Device Sequence Number | 1 |
Product Code |
KRD
|
UDI-Device Identifier | 08714729764960 |
UDI-Public | 08714729764960 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K132578 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,distri |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
11/03/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 11/03/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 11/22/2023 |
Device Model Number | 83779 |
Device Catalogue Number | 83779 |
Device Lot Number | 0026555809 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 10/12/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 12/22/2020 |
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 | GUIDEWIRE-FATHOM; INTRODUCER SHEATH-TERUMO 8F SHEATH; MICRO CATHETER-BREAKTHROUGH 2M |