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 |
alison
sweeney
|
parkmore business park west |
galway
|
EI
|
091708096
|
|
MDR Report Key | 13863628 |
MDR Text Key | 287805620 |
Report Number | 3002648230-2022-00108 |
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 |
Foreign,Study,Health Professional,Company Representative |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
03/22/2022 |
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 | 06/09/2023 |
Device Model Number | 4FC12 |
Device Catalogue Number | 4FC12 |
Device Lot Number | 0010706107 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/07/2022 |
Initial Date FDA Received | 03/23/2022 |
Date Device Manufactured | 06/09/2021 |
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) |
Hospitalization;
Required Intervention;
|
Patient Age | 73 YR |
Patient Sex | Female |
Patient Weight | 50 KG |
|
|