Brand Name | RANGER PACLITAXEL-COATED PTA BALLOON CATHETER |
Type of Device | DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
300 boston scientific way |
marlborough MA 01752 |
|
Manufacturer (Section G) |
HEMOTEQ AG |
adenauerstrasse 15 |
|
wuerselen 52146 |
GM
52146
|
|
Manufacturer Contact |
rachel
shields
|
4100 hamline ave n |
arden hills, MN 55112
|
6512422111
|
|
MDR Report Key | 18848441 |
MDR Text Key | 337622007 |
Report Number | 2124215-2024-13413 |
Device Sequence Number | 1 |
Product Code |
ONU
|
UDI-Device Identifier | 08714729976196 |
UDI-Public | 08714729976196 |
Combination Product (y/n) | Y |
Reporter Country Code | JA |
PMA/PMN Number | P190019 |
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 |
Report Date |
03/06/2024 |
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 | 1973-03 |
Device Catalogue Number | 1973-03 |
Device Lot Number | 07034H22 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/14/2024
|
Initial Date FDA Received | 03/06/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/29/2022 |
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 | GUIDEWIRE: 014 VASSALLO FLOPPY |