Brand Name | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM |
Type of Device | CATHETER, CORONARY, ATHERECTOMY |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - FREMONT (CE) |
47215 lakeview blvd |
north dock |
fremont CA 94538 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - FREMONT (CE) |
47215 lakeview blvd |
north dock |
fremont CA 94538 |
|
Manufacturer Contact |
sonali
arangil
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 6196564 |
MDR Text Key | 63048592 |
Report Number | 2134265-2016-11378 |
Device Sequence Number | 1 |
Product Code |
MCX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P900056 |
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 |
11/21/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | H802220200291 |
Device Catalogue Number | 22020-029 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/21/2016
|
Initial Date FDA Received | 12/21/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
Treatment | 1.50MM ROTALINK¿ PLUS; DYNAGLIDE FOOT PEDAL; ROTAWIRE |
Patient Outcome(s) |
Death;
|