Brand Name | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM |
Type of Device | CATHETER, CORONARY, ATHERECTOMY |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
2546 first street |
propark free zone |
alajuela |
CS |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - CORK |
business and technology park |
model farm road |
cork |
EI
|
|
Manufacturer Contact |
linda
leimer
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 5393677 |
MDR Text Key | 36899840 |
Report Number | 2134265-2016-00114 |
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 |
other |
Reporter Occupation |
Patient Family Member or Friend
|
Type of Report
| Initial |
Report Date |
01/05/2016 |
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 | UNK509 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
01/05/2016
|
Initial Date FDA Received | 01/27/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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) |
Death;
|