Brand Name | ROTALINK PLUS |
Type of Device | CATHETER, CORONARY, ATHERECTOMY |
Manufacturer (Section D) |
BOSTON SCIENTIFIC CORPORATION |
two scimed place |
maple grove MN 55311 |
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC CORK LIMITED |
model farm road |
|
cork |
EI
|
|
Manufacturer Contact |
jay
johnson
|
two scimed place |
maple grove, MN 55311
|
7634942574
|
|
MDR Report Key | 10936694 |
MDR Text Key | 219336447 |
Report Number | 2134265-2020-16760 |
Device Sequence Number | 1 |
Product Code |
MCX
|
UDI-Device Identifier | 08714729228363 |
UDI-Public | 08714729228363 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P900056 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/02/2020 |
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 Expiration Date | 07/05/2022 |
Device Model Number | 3241 |
Device Catalogue Number | 3241 |
Device Lot Number | 0025810071 |
Was Device Available for Evaluation? |
No
|
Initial Date Manufacturer Received |
11/23/2020
|
Initial Date FDA Received | 12/02/2020 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/04/2020 |
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 |