Brand Name | JETSTREAM XC ATHERECTOMY CATHETER |
Type of Device | CATHETER, PERIPHERAL, ATHERECTOMY |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
model farm road |
|
cork |
EI
|
|
Manufacturer Contact |
jay
johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 10505737 |
MDR Text Key | 206098168 |
Report Number | 2134265-2020-12190 |
Device Sequence Number | 1 |
Product Code |
MCW
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K130637 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
09/08/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/08/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/08/2022 |
Device Model Number | 45007 |
Device Catalogue Number | 45007 |
Device Lot Number | 0025686868 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 08/21/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/08/2020 |
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 |
Treatment | MEDTRONIC SPIDER EMBOLIC PROTECTION SYSTEM; PENUMBRA CAT6 CATHETER; PENUMBRA SEPARATOR; RANGER BALLOON 4MM; RANGER BALLOON 5MM; THRUWAY .014 GUIDEWIRE |
Patient Outcome(s) |
Required Intervention;
|
Patient Age | 54 YR |