Brand Name | EXPRESS SD RENAL/BILIARY |
Type of Device | CATHETER, BILIARY, DIAGNOSTIC |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC SCIMED, INC |
two scimed place |
|
maple grove MN 55311 |
|
Manufacturer Contact |
sonali
arangil
|
two scimed place |
maple grove, MN 55311
|
6515827403
|
|
MDR Report Key | 8161980 |
MDR Text Key | 130262209 |
Report Number | 2134265-2018-64081 |
Device Sequence Number | 1 |
Product Code |
NIN
|
UDI-Device Identifier | 08714729484844 |
UDI-Public | 08714729484844 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K152607 |
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 |
12/13/2018 |
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 | 09/13/2020 |
Device Model Number | 20188 |
Device Catalogue Number | 20188 |
Device Lot Number | 0021133230 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/28/2018
|
Initial Date FDA Received | 12/13/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/14/2017 |
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 | 300CM V-18 GUIDEWIRE; 5X20MM STERLING RX PRE-DILATATION BALLOON; 6FR X 11CM SHEATH; 6FR X 55CM LIMA MACH 1 GUIDE CATHETER |
Patient Age | 84 YR |