Brand Name | GALEO PRO F CORONARY GUIDEWIRE |
Type of Device | CORONARY GUIDEWIRE |
Manufacturer (Section D) |
CONCERT MEDICAL, LLC |
77 accord park drive |
norwell MA 02061 |
|
Manufacturer (Section G) |
CONCERT MEDICAL, LLC |
77 accord park drive |
|
norwell MA 02061 |
|
Manufacturer Contact |
timothy
powers
|
77 accord park drive |
norwell, MA 02061
|
7812617407
|
|
MDR Report Key | 6241522 |
MDR Text Key | 64616869 |
Report Number | 1223414-2017-00002 |
Device Sequence Number | 1 |
Product Code |
DQX
|
UDI-Device Identifier | 00814384020215 |
UDI-Public | 00814384020215 |
Combination Product (y/n) | N |
Reporter Country Code | SZ |
PMA/PMN Number | K090193 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor,foreign,health pr |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/10/2017 |
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 |
Physician
|
Device Expiration Date | 10/31/2019 |
Device Model Number | 512040-002 |
Device Catalogue Number | 389783 |
Device Lot Number | 00577932 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/22/2016 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
11/29/2016
|
Initial Date FDA Received | 01/11/2017 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/14/2014 |
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 | GUIDING CATHETER |
Patient Outcome(s) |
Other;
|
Patient Age | 65 YR |
|
|