Brand Name | DIREXION HI-FLO FATHOM-16 SYSTEM |
Type of Device | CATHETER, CONTINUOUS FLUSH |
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
|
4100 hamline ave n |
arden hills, MN 55112
|
6515810888
|
|
MDR Report Key | 15513547 |
MDR Text Key | 301498508 |
Report Number | 2124215-2022-37882 |
Device Sequence Number | 1 |
Product Code |
KRA
|
UDI-Device Identifier | 08714729839712 |
UDI-Public | 08714729839712 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K142259 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
09/29/2022 |
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 | 01/21/2024 |
Device Model Number | 84591 |
Device Catalogue Number | 84591 |
Device Lot Number | 0028721418 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/23/2022 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
09/08/2022 |
Initial Date FDA Received | 09/30/2022 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/21/2022 |
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 |