Brand Name | ULTRAFLEX IAB: 7.5FR 30CC |
Type of Device | SYSTEM, BALLOON, INTRA-AORTIC |
Manufacturer (Section D) |
ARROW INTERNATIONAL LLC |
morrisville NC |
|
Manufacturer (Section G) |
ARROW INTERNATIONAL INC. |
16 elizabeth drive |
|
chelmsford MA 01824 |
|
Manufacturer Contact |
bryanna
connelly
|
3015 carrington mill blvd |
morrisville 27560
|
|
MDR Report Key | 18507572 |
MDR Text Key | 333246665 |
Report Number | 3010532612-2024-00049 |
Device Sequence Number | 1 |
Product Code |
DSP
|
UDI-Device Identifier | 00801902003751 |
UDI-Public | 00801902003751 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K000729 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,User Facility,Distributor |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
01/08/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 01/12/2024 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | IAB-06830-U |
Device Lot Number | 18F23K0061 |
Was Device Available for Evaluation? |
Yes
|
Date Manufacturer Received | 01/08/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 10/31/2023 |
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 Age | 66 YR |
Patient Sex | Male |