Brand Name | ADMIRAL XTREME OTW |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
MEDTRONIC MEXICO |
avenida paseo del cucapah |
parque industrial el lago |
tijuana,bc 22570 |
MX 22570 |
|
Manufacturer (Section G) |
MEDTRONIC MEXICO |
avenida paseo del cucapah |
parque industrial el lago |
tijuana,bc 22570 |
MX
22570
|
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
091708734
|
|
MDR Report Key | 7536180 |
MDR Text Key | 108977120 |
Report Number | 9612164-2018-01196 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
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 |
Report Date |
05/23/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/20/2020 |
Device Catalogue Number | SBI050120130 |
Device Lot Number | 214054593 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 05/08/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/25/2018 |
Initial Date FDA Received | 05/23/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/20/2017 |
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 | 76 YR |
|
|