FDA Adverse Event
Injury
Summary report: N
IAB: 8 FR- 40 CC
MDR report key: 1003992
·
Received February 25, 2008
Report
- Report Number
- 1219856-2008-00071
- Event Type
- Injury
- Date Received
- February 25, 2008
- Date of Event
- January 28, 2008
- Report Date
- February 25, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K040801
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
EVENT WAS REPORTED VIA A MEDWATCH FORM. IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED IN 2008. THE IAB WAS PLACED EMERGENTLY DURING URGENT CORONARY ARTERY BYPASS GRAFT SURGERY AND REPAIR OF VENTRICULAR ANEURYSM. PT IS LISTED FOR HEART TRANSPLANT LIST. ON THE NEXT DAY, THE HIGH PRESSURE ALARM SOUNDED AND CRYSTALLIZED BLOOD WAS NOTED IN DRIVELINE. BALLOON COULD NOT BE REMOVED. PT TAKEN EMERGENTLY TO THE OPERATING ROOM. ARTERIOTOMY WITH REPAIR REQUIRED FOR BALLOON REMOVAL. SOLID STRUCTURE 1.5CM FOUND. UPDATE THE FOLLOWING MONTH - "THE PT IS FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB: 8 FR- 40 CC | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTL., INC. | MF6026124 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |