Brand Name | FLEXCATH ADVANCE STEERABLE SHEATH |
Type of Device | CATHETER, STEERABLE |
Manufacturer (Section D) |
MEDTRONIC CRYOCATH LP |
9000 autoroute transcanadienne |
pointe-claire,qc H9H 5 H3 |
CA H9H 5H3 |
|
Manufacturer (Section G) |
MEDTRONIC CRYOCATH LP |
9000 autoroute transcanadienne |
|
pointe-claire,qc H9H 5 H3 |
CA
H9H 5H3
|
|
Manufacturer Contact |
anne
schilling
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635052036
|
|
MDR Report Key | 6087461 |
MDR Text Key | 59450680 |
Report Number | 3002648230-2016-00479 |
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 |
Report Date |
10/17/2016 |
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? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 07/15/2018 |
Device Model Number | 4FC12 |
Device Catalogue Number | 4FC12 |
Device Lot Number | 29930 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
10/17/2016 |
Initial Date FDA Received | 11/08/2016 |
Supplement Dates Manufacturer Received | Not provided 11/29/2016
|
Supplement Dates FDA Received | 12/08/2016 09/27/2017
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/15/2016 |
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 |
Patient Outcome(s) |
Life Threatening;
Required Intervention;
|
|
|