Brand Name | SMALL PERIPHERAL CUTTING BALLOON? |
Type of Device | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - GALWAY |
ballybrit business park |
galway |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - GALWAY |
ballybrit business park |
|
galway |
|
Manufacturer Contact |
linda
leimer
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 4859577 |
MDR Text Key | 5808375 |
Report Number | 2134265-2015-04150 |
Device Sequence Number | 1 |
Product Code |
NWX
|
Combination Product (y/n) | N |
PMA/PMN Number | P950020 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
05/26/2015 |
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 | M001BPM4015140F0 |
Device Catalogue Number | BPM4015140F |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
05/26/2015 |
Initial Date FDA Received | 06/22/2015 |
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 |