Brand Name | FLEXCATH ADVANCE STEERABLE SHEATH |
Type of Device | CATHETER, STEERABLE |
Manufacturer (Section D) |
MEDTRONIC CRYOCATH LP |
9000 autoroute transcanadienne |
pointe claire,qc H9R 5 Z8 |
CA H9R 5Z8 |
|
Manufacturer (Section G) |
MEDTRONIC CRYOCATH LP |
9000 autoroute transcanadienne |
|
pointe claire,qc H9R 5 Z8 |
CA
H9R 5Z8
|
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 6072420 |
MDR Text Key | 58936831 |
Report Number | 3002648230-2016-00469 |
Device Sequence Number | 1 |
Product Code |
DRA
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K123591 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
12/12/2016 |
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 | 07/07/2018 |
Device Model Number | 4FC12 |
Device Catalogue Number | 4FC12 |
Device Lot Number | 26889 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 11/14/2016 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/06/2016 |
Initial Date FDA Received | 11/02/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided Not provided
|
Supplement Dates FDA Received | 01/05/2017 02/17/2017 02/17/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/07/2016 |
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 |