Brand Name | ROTAREXS 6F 135CM (STRAUB MEDICAL) |
Type of Device | ATHERECTOMY CATHETER |
Manufacturer (Section D) |
STRAUB MEDICAL AG |
straubstrasse 12 |
wangs, sankt gallen 7323 |
SZ 7323 |
|
MDR Report Key | 10389656 |
MDR Text Key | 202348438 |
Report Number | 3008439199-2020-00036 |
Device Sequence Number | 1 |
Product Code |
MCW
|
UDI-Device Identifier | 07640142810582 |
UDI-Public | 7640142810582 |
Combination Product (y/n) | N |
PMA/PMN Number | K172315 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
07/15/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/30/2023 |
Device Model Number | SET ROTAREX®S 6F X 135CM |
Device Catalogue Number | 80237 |
Device Lot Number | 200664 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/10/2020 |
Initial Date Manufacturer Received |
07/15/2020 |
Initial Date FDA Received | 08/11/2020 |
Supplement Dates Manufacturer Received | 07/15/2020
|
Supplement Dates FDA Received | 10/01/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Hospitalization;
Required Intervention;
|
Patient Age | 73 YR |
|
|