FDA Adverse Event
Malfunction
Summary report: N
IAB: 7.5 FR - 40 CC
MDR report key: 2033890
·
Received February 11, 2011
Report
- Report Number
- 1219856-2011-00054
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- January 26, 2011
- Report Date
- February 7, 2011
- Manufacturer
- ARROW INTL., INC.
- Product Code
- DSP
- PMA / PMN Number
- K000729
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED AND WHEN THE TUBING WAS FLUSHED, THERE WAS A LEAK FOUND AT THE CONNECTION TO THE STOPCOCK. AS A RESULT, THE TUBING WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. IAB THERAPY WAS NOT DELAYED OR INTERRUPTED. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT OUTCOME IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IAB: 7.5 FR - 40 CC | INTRA-AORTIC BALLOON PRODUCTS | DSP | ARROW INTL., INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |