Brand Name | 2CM PERIPHERAL CUTTING BALLOON |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC IRELAND LIMITED |
ballybrit business park |
|
galway |
EI
|
|
Manufacturer Contact |
jay
johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 9526558 |
MDR Text Key | 177141301 |
Report Number | 2134265-2019-16228 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (Y/N) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
COMPANY REPRESENTATIVE,DISTRI |
Reporter Occupation |
|
Type of Report
| Initial,Followup |
Report Date |
02/06/2020 |
1 Device Was Involved in the Event |
|
0 PatientS WERE Involved in the Event: | |
Date FDA Received | 12/27/2019 |
Is This An Adverse Event Report? |
No
|
Is This A Product Problem Report? |
Yes
|
Device Operator |
HEALTH PROFESSIONAL
|
Device MODEL Number | 24630 |
Device Catalogue Number | 24630 |
Device LOT Number | 0023801848 |
Was Device Available For Evaluation? |
Device Returned To Manufacturer
|
Date Returned to Manufacturer | 01/02/2020 |
Is The Reporter A Health Professional? |
Yes
|
Was the Report Sent to FDA? |
|
Event Location |
No Information
|
Date Manufacturer Received | 01/29/2020 |
Was Device Evaluated By Manufacturer? |
Yes
|
Date Device Manufactured | 05/16/2019 |
Is The Device Single Use? |
Yes
|
Is this a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|