Brand Name | PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER |
Type of Device | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY |
Manufacturer (Section D) |
BIOSENSE WEBSTER, INC. (JUAREZ) |
circuito interior norte #1820 |
parque industrial salvacar |
juarez, chihuahua 32599 |
MX 32599 |
|
Manufacturer (Section G) |
BIOSENSE WEBSTER, INC. (JUAREZ) |
circuito interior norte #1820 |
parque industrial salvacar |
juarez, chihuahua 32599 |
MX
32599
|
|
Manufacturer Contact |
joaquin
kurz
|
33 technology drive |
irvine, CA 92618
|
9497893837
|
|
MDR Report Key | 6201554 |
MDR Text Key | 63187521 |
Report Number | 9673241-2016-00892 |
Device Sequence Number | 1 |
Product Code |
MTD
|
Combination Product (y/n) | N |
Reporter Country Code | FR |
PMA/PMN Number | K123837 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup |
Report Date |
11/24/2016 |
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 Expiration Date | 04/30/2019 |
Device Model Number | D-1282-08-S |
Device Catalogue Number | D128208 |
Device Lot Number | 17487617L |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
11/24/2016 |
Initial Date FDA Received | 12/22/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided
|
Supplement Dates FDA Received | 01/19/2017 01/20/2017
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 05/26/2016 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Other;
|
|
|