FDA Adverse Event
Death
Summary report: N
MEGA 8FR IAB
MDR report key: 3812322
·
Received May 6, 2014
Report
- Report Number
- 2248146-2014-00074
- Event Type
- Death
- Date Received
- May 6, 2014
- Report Date
- April 7, 2014
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K091449
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED BY THE FACILITY AND SENT TO A THIRD PARTY FOR DECONTAMINATION. A SUPPLEMENTAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE FACILITY THAT THEY WERE UNABLE TO ADVANCE THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH. A NEW SHEATH AND IAB WAS USED WITH THE SAME RESULT. ON DAY THREE A SUCCESSFUL INSERTION WAS ACHIEVED AFTER FURTHER DETERIORATION. IT WAS REPORTED THAT THE PATIENT EXPIRED. RELATED TO MFR REPORT NOS: 2248146-2014-00075, 2248146-2014-00077.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271974 | MEGA 8FR IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0684-00-0497 | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death |