Brand Name | RANGER PACLITAXEL-COATED PTA BALLOON CATHETER |
Type of Device | DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORPORATION |
|
|
|
|
Manufacturer Contact |
jay
johnson
|
4100 hamline ave n |
arden hills, MN 55112
|
6515810888
|
|
MDR Report Key | 15126135 |
MDR Text Key | 296842902 |
Report Number | 2134265-2022-08197 |
Device Sequence Number | 1 |
Product Code |
ONU
|
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 |
Foreign,Health Professional,Company Representative,Distributor |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
07/28/2022 |
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? |
No
|
Device Operator |
Health Professional
|
Device Model Number | 1973-03 |
Device Catalogue Number | 1973-03 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
07/05/2022
|
Initial Date FDA Received | 07/28/2022 |
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 |
Patient Outcome(s) |
Other;
|
Patient Sex | Female |