Brand Name | PASSEO-18 6/80/130 |
Type of Device | CATHETER, ANGIOPLASTY, BALLOON DILATATION |
Manufacturer (Section D) |
BIOTRONIK AG |
ackerstrasse 6 |
buelach CH-81 80 |
SZ
CH-8180
|
|
Manufacturer Contact |
|
6024 jean road |
lake oswego, OR 97035
|
8772459800
|
|
MDR Report Key | 7846113 |
MDR Text Key | 119255415 |
Report Number | 1028232-2018-03029 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (Y/N) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K072765 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,FOREIG |
Reporter Occupation |
OTHER HEALTH CARE PROFESSIONAL
|
Type of Report
| Initial,Followup |
Report Date |
08/30/2018 |
1 Device Was Involved in the Event |
|
1 Patient Was Involved in the Event | |
Date FDA Received | 09/05/2018 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device EXPIRATION Date | 11/30/2020 |
Device MODEL Number | 366124 |
Device Catalogue Number | SEE MODEL NO. |
Device LOT Number | 11175268 |
Was Device Available For Evaluation? |
No
|
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 10/03/2018 |
Was Device Evaluated By Manufacturer? |
Device Not Returned To Manufacturer
|
Date Device Manufactured | 12/04/2017 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient TREATMENT DATA |
Date Received: 09/05/2018 Patient Sequence Number: 1 |
|
|