Brand Name | WOLVERINE CORONARY CUTTING BALLOON MONORAIL |
Type of Device | CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
ballybrit business park |
|
galway |
EI
|
|
Manufacturer Contact |
rachel
shields
|
4100 hamline ave n |
arden hills, MN 55112
|
6512422111
|
|
MDR Report Key | 18790567 |
MDR Text Key | 337529236 |
Report Number | 2124215-2024-11668 |
Device Sequence Number | 1 |
Product Code |
NWX
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
04/18/2024 |
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 | 3851 |
Device Catalogue Number | 3851 |
Device Lot Number | 0031268010 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/14/2024
|
Initial Date FDA Received | 02/27/2024 |
Supplement Dates Manufacturer Received | 03/29/2024
|
Supplement Dates FDA Received | 04/18/2024
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 03/20/2023 |
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 |
Treatment | GUIDE CATHETER: TERUMO HR 6FR BR; GUIDE CATHETER: TERUMO HR 6FR BR |