Brand Name | EXPO GUIDE CATHETER |
Type of Device | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
FLEXTRONICS INTERNATIONL EUROPE B V |
6201 america center drive |
|
san jose CA 95002 |
|
Manufacturer Contact |
jay johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 13297118 |
MDR Text Key | 285772640 |
Report Number | 2134265-2022-00451 |
Device Sequence Number | 1 |
Product Code |
DQO
|
UDI-Device Identifier | 08714729187691 |
UDI-Public | 08714729187691 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K120495 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility,Company Representative |
Reporter Occupation |
Risk Manager
|
Type of Report
| Initial |
Report Date |
01/19/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/19/2022 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 07/30/2023 |
Device Model Number | 7840 |
Device Catalogue Number | 7840 |
Device Lot Number | 0060310965 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 12/29/2021 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/30/2021 |
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 |
Patient Outcome(s) |
Required Intervention;
|