Brand Name | 2CM PERIPHERAL CUTTING BALLOON® |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - GALWAY |
|
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - GALWAY |
|
|
|
|
Manufacturer Contact |
sonali
arangil
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 6814738 |
MDR Text Key | 83432994 |
Report Number | 2134265-2017-08368 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K070951 |
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 |
08/03/2017 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 04/26/2019 |
Device Model Number | M001PCB6020900 |
Device Catalogue Number | PCB602090 |
Device Lot Number | 20568528 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
08/03/2017 |
Initial Date FDA Received | 08/23/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 05/19/2017 |
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) |
Required Intervention;
|