FDA Adverse Event
Injury
Summary report: N
IAB: 9 FR - 50 CC
MDR report key: 1060641
·
Received June 13, 2008
Report
- Report Number
- 1219856-2008-00282
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 13, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K010330
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. MD INSERTED THE IAB WITHOUT USING A SHEATH. FIVE MINS AFTER THE IAB WAS INSERTED THE PUMP ALARMED AND BLOOD WAS SEEN IN THE HELIUM TUBING. THE IAB WAS REMOVED AND ANOTHER IAB WAS INSERTED IN A DIFFERENT INSERTION SITE WITHOUT DIFFICULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB: 9 FR - 50 CC | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTL., INC. | MR8039844 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |