FDA Adverse Event
Injury
Summary report: N
IAB : 8FR- 40 CC
MDR report key: 1003991
·
Received February 25, 2008
Report
- Report Number
- 1219856-2008-00070
- Event Type
- Injury
- Date Received
- February 25, 2008
- Date of Event
- February 13, 2008
- Report Date
- February 25, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K981660
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE MD INSERTED THE IAB THROUGH A SHEATH VIA THE FEMORAL ARTERY. AFTER INSERTION, THE ONE-WAY BLUE VALVE WAS CLOSED, "WITHDRAWAL VACUUM TWICE", AND FLUSHED THE CENTRAL LUMEN WITH " HEPARINIZED NORMAL SALINE". THE MD FOUND THE " HEPARINIZED NORMAL SALINE INFILTRATED INTO THE BALLOON." AS A RESULT, THE IAB WAS REMOVED AND ANOTHER IAB WAS INSERTED. THERE WERE NO REPORTED PT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB : 8FR- 40 CC | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTL., INC. | MF6057768 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | HEPARIZINED NORMAL SALINE |