FDA Adverse Event
Malfunction
Summary report: N
IAB: 7.5 FR - 40 CC
MDR report key: 1031467
·
Received April 18, 2008
Report
- Report Number
- 1219856-2008-00197
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- April 3, 2008
- Report Date
- April 18, 2008
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K021462
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CUSTOMER THAT THEY COULD NOT PASS THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH AFTER 3 TO 4 ATTEMPTS. AS A RESULT, AN 8 FR 40CC ARROW IAB WAS INSERTED WITHOUT FURTHER DIFFICULTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB: 7.5 FR - 40 CC | INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) | DSP | ARROW INTL., INC. | MF7034178 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |