Brand Name | ROTAREXS 6F 110CM (STRAUB MEDICAL) |
Type of Device | ATHERECTOMY CATHETER |
Manufacturer (Section D) |
STRAUB MEDICAL AG |
straubstrasse 12 |
wangs, sankt gallen 7323 |
SZ 7323 |
|
MDR Report Key | 10158002 |
MDR Text Key | 195920194 |
Report Number | 3008439199-2020-00007 |
Device Sequence Number | 1 |
Product Code |
MCW
|
UDI-Device Identifier | 07640142810278 |
UDI-Public | 7640142810278 |
Combination Product (y/n) | N |
PMA/PMN Number | K172315 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,study,use |
Type of Report
| Initial,Followup,Followup |
Report Date |
05/18/2020 |
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 | 02/07/2023 |
Device Model Number | ROTAREX®S 6F X 110CM |
Device Catalogue Number | 80208 |
Device Lot Number | 200123 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/18/2020 |
Initial Date Manufacturer Received |
05/18/2020 |
Initial Date FDA Received | 06/16/2020 |
Supplement Dates Manufacturer Received | 05/18/2020 05/18/2020
|
Supplement Dates FDA Received | 07/03/2020 09/28/2020
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 65 YR |
Patient Weight | 71 |
|
|