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 |
paula
bixby
|
8200 coral sea st ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 12108596 |
MDR Text Key | 259660968 |
Report Number | 3002648230-2021-00334 |
Device Sequence Number | 1 |
Product Code |
DRA
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
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 |
Report Date |
07/02/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 07/02/2021 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/16/2022 |
Device Model Number | 4FC12 |
Device Catalogue Number | 4FC12 |
Device Lot Number | 0010080671 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 06/16/2021 |
Date Device Manufactured | 01/17/2020 |
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 |
Treatment | 990063-020 MAPPING CATHETER |
Patient Outcome(s) |
Hospitalization;
Life Threatening;
Required Intervention;
|
Patient Age | 71 YR |
Patient Weight | 51 |