Brand Name | ADMIRAL XTREME |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
MEDTRONIC MEXICO |
av. paseo del cucapah #10510 |
tijuana,bc 22570 |
MX 22570 |
|
Manufacturer (Section G) |
MEDTRONIC MEXICO |
av. paseo del cucapah #10510 |
|
tijuana,bc 22570 |
MX
22570
|
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
091708734
|
|
MDR Report Key | 7361650 |
MDR Text Key | 103171371 |
Report Number | 9612164-2018-00547 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Reporter Country Code | NZ |
PMA/PMN Number | K062809 |
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 |
Report Date |
04/27/2018 |
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 | UNK-CV-GWY-SBI |
Device Catalogue Number | UNK-CV-GWY-SBI |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/06/2018 |
Initial Date FDA Received | 03/22/2018 |
Supplement Dates Manufacturer Received | 04/12/2018
|
Supplement Dates FDA Received | 04/27/2018
|
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) |
Required Intervention;
|
Patient Age | 72 YR |
|
|