Brand Name | FLEXTOME CUTTING BALLOON |
Type of Device | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC IRELAND LIMITED |
ballybrit business park |
|
galway |
EI
|
|
Manufacturer Contact |
sonali
arangil
|
two scimed place |
maple grove, MN 55311
|
6515827403
|
|
MDR Report Key | 8187413 |
MDR Text Key | 131140688 |
Report Number | 2134265-2018-64374 |
Device Sequence Number | 1 |
Product Code |
NWX
|
UDI-Device Identifier | 08714729808428 |
UDI-Public | 08714729808428 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P950020 |
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 |
12/20/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 03/11/2021 |
Device Model Number | 3824 |
Device Catalogue Number | 3824 |
Device Lot Number | 0021847477 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/10/2018
|
Initial Date FDA Received | 12/20/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 03/12/2018 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |