Brand Name | JETSTREAM® XC ATHERECTOMY CATHETER |
Type of Device | CATHETER, PERIPHERAL, ATHERECTOMY |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - CORK |
business and technology park |
model farm road |
cork |
EI |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - CORK |
business and technology park |
model farm road |
cork |
EI
|
|
Manufacturer Contact |
sonali
arangil
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 6507649 |
MDR Text Key | 73269141 |
Report Number | 2134265-2017-03812 |
Device Sequence Number | 1 |
Product Code |
MCW
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K130637 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
04/03/2017 |
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 | 08/31/2018 |
Device Model Number | 112266-001 |
Device Catalogue Number | PV41340 |
Device Lot Number | 19704379 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/03/2017 |
Initial Date FDA Received | 04/20/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/19/2016 |
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 |