FDA Adverse Event
Injury
Summary report: N
IAB : 7.5 FR -30 CC
MDR report key: 1003994
·
Received February 25, 2008
Report
- Report Number
- 1219856-2008-00066
- Event Type
- Injury
- Date Received
- February 25, 2008
- Date of Event
- January 22, 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
- AA, JA
- 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 CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. A SHEATH WAS INSERTED VIA THE FEMORAL ARTERY. THE MD WAS UNABLE TO INSERT THE IAB THROUGH THE SHEATH BECAUSE IT BECAME STUCK. AS A RESULT, THE IAB WAS REMOVED WITH THE SHEATH AS ONE UNIT; ANOTHER IAB WAS INSERTED WITH SUCCESS. THERE WERE NO REPORTED PT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB : 7.5 FR -30 CC | INTRA-AORITC BALLOON PRODUCTS | DSP | ARROW INTL., INC. | MF6089991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Required Intervention |