Brand Name | PACIFIC XTREME |
Type of Device | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL |
Manufacturer (Section D) |
INVATEC SPA |
via martiri della liberta, 7 |
roncadelle 25030 |
IT 25030 |
|
Manufacturer (Section G) |
INVATEC SPA |
via martiri della liberta, 7 |
|
roncadelle 25030 |
IT
25030
|
|
Manufacturer Contact |
toni
o'doherty
|
parkmore business park west |
galway
|
091708734
|
|
MDR Report Key | 6720592 |
MDR Text Key | 80246769 |
Report Number | 3004066202-2017-00072 |
Device Sequence Number | 1 |
Product Code |
LIT
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | K103464 |
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 |
06/23/2017 |
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 Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/23/2017 |
Initial Date FDA Received | 07/18/2017 |
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 | 73 YR |
Patient Weight | 65 |
|
|