Brand Name | FLEXIMA BILIARY |
Type of Device | CATHETER, BILIARY, DIAGNOSTIC |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
780 brookside drive |
|
spencer IN 47460 |
|
Manufacturer Contact |
carole
morley
|
300 boston scientific way |
marlborough, MA 01752
|
5086834015
|
|
MDR Report Key | 18446494 |
MDR Text Key | 331939235 |
Report Number | 3005099803-2023-06965 |
Device Sequence Number | 1 |
Product Code |
FGE
|
UDI-Device Identifier | 08714729162629 |
UDI-Public | 08714729162629 |
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K965147 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Company Representative,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/04/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/04/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | M00539310 |
Device Catalogue Number | 3931 |
Device Lot Number | 0032813706 |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 12/12/2023 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 11/08/2023 |
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 |
|
|