FDA Adverse Event
Injury
Summary report: N
IAB: 8 FR - 30 CC
MDR report key: 1022596
·
Received April 1, 2008
Report
- Report Number
- 1219856-2008-00165
- Event Type
- Injury
- Date Received
- April 1, 2008
- Date of Event
- February 19, 2008
- Report Date
- April 1, 2008
- Manufacturer
- ARROW INTERNATIONAL INC.
- Product Code
- DSP
- PMA / PMN Number
- K040801
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE MD INSERTED THE SHEATH VIA THE FEMORAL ARTERY. WHILE ADVANCING THE INTRA-AORTA BALLOON (IAB) THROUGH THE SHEATH, IT BECAME STUCK. THE IAB WAS REMOVED WITH THE SHEATH AND ANOTHER IAB WAS INSERTED WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB: 8 FR - 30 CC | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTERNATIONAL INC. | MF7118003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |