Brand Name | BALLOON CATHETER INFLATION DEVICES |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
2546 first street |
propark free zone |
alajuela |
CS |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - COSTA RICA (COYOL) |
2546 first street |
propark free zone |
alajuela |
CS
|
|
Manufacturer Contact |
sonali
arangil
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 6414397 |
MDR Text Key | 70315850 |
Report Number | 2134265-2017-02280 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Reporter Country Code | AU |
PMA/PMN Number | K875064 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial |
Report Date |
03/06/2017 |
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 Model Number | UNK614 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/06/2017 |
Initial Date FDA Received | 03/17/2017 |
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 |