Brand Name | STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON |
Type of Device | DCB PTA CATHETER |
Manufacturer (Section D) |
SPECTRANETICS |
6531 dumbarton circle |
fremont CA 94555 |
|
Manufacturer (Section G) |
SPECTRANETICS |
6531 dumbarton circle |
|
fremont CA 94555 |
|
Manufacturer Contact |
florie
cazem
|
5055 brandin court |
fremont, CA 94538
|
510933-792
|
|
MDR Report Key | 7450356 |
Report Number | 3009784280-2018-00049 |
Device Sequence Number | 1 |
Product Code |
ONU
|
Reporter Country Code | BE |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign,study |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
01/01/2005,04/06/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 05/02/2013 |
Device Model Number | A35DC06008013IU |
Device Catalogue Number | A35DC06008013IU |
Device Lot Number | 13A2960801 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 01/01/2005 |
Date Report to Manufacturer | 01/10/2005 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 04/23/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 01/30/2013 |
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) |
Other;
|
Patient Age | 63 YR |
Patient Weight | 80 |
|
|