Brand Name | IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER |
Type of Device | DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS |
Manufacturer (Section D) |
MEDTRONIC IRELAND |
parkmore business park west |
galway |
EI |
|
Manufacturer (Section G) |
MEDTRONIC IRELAND |
parkmore business park west |
|
galway |
EI
|
|
Manufacturer Contact |
alison
sweeney
|
parkmore business park west |
galway
|
EI
|
091708096
|
|
MDR Report Key | 13597297 |
MDR Text Key | 286111498 |
Report Number | 9612164-2022-00786 |
Device Sequence Number | 1 |
Product Code |
ONU
|
Combination Product (y/n) | N |
Reporter Country Code | GM |
PMA/PMN Number | P140010 |
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 |
02/25/2022 |
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 | 04/16/2022 |
Device Catalogue Number | SBI06012013P |
Device Lot Number | 0009689049 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
02/18/2022
|
Initial Date FDA Received | 02/25/2022 |
Date Device Manufactured | 04/17/2019 |
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 | 63 YR |
Patient Sex | Male |
Patient Weight | 95 KG |