Brand Name | PASSEO-18 5/200/90 |
Type of Device | PERIPHERAL DILATATION CATHETER |
Manufacturer (Section D) |
BIOTRONIK AG, BUELACH, SWITZERLAND |
ackerstrasse 6 |
buelach CH-81 80 |
CH CH-8180 |
|
Manufacturer Contact |
|
6024 jean road |
lake oswego, OR 97035
|
8772459800
|
|
MDR Report Key | 13003204 |
MDR Text Key | 282224823 |
Report Number | 1028232-2021-06742 |
Device Sequence Number | 1 |
Product Code |
LIT
|
UDI-Device Identifier | 07640130429888 |
UDI-Public | 07640130429888 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K151744 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
12/09/2021 |
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 | 04/30/2024 |
Device Model Number | 376281 |
Device Catalogue Number | SEE MODEL NO. |
Device Lot Number | 04215345 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/06/2021 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/09/2021 |
Initial Date FDA Received | 12/14/2021 |
Supplement Dates Manufacturer Received | 12/27/2021
|
Supplement Dates FDA Received | 12/29/2021
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 05/31/2021 |
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 |
|
|