Type of Device | CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER |
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 3259 9 |
MX
32599
|
|
Manufacturer Contact |
jaime
chavez
|
15715 arrow highway |
irwindale, CA 91706
|
9098398483
|
|
MDR Report Key | 3792880 |
MDR Text Key | 4479170 |
Report Number | 9673241-2014-00178 |
Device Sequence Number | 1 |
Product Code |
OAD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P030031 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/16/2014 |
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 | GENERIC - EZ STEER NAV (TC) |
Device Lot Number | UNKNOWN_D-1292-00 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
04/15/2014
|
Initial Date FDA Received | 05/06/2014 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Life Threatening;
|
|
|