FDA Adverse Event
Death
Summary report: N
SENSATION PLUS 50CC IAB
MDR report key: 3760690
·
Received April 8, 2014
Report
- Report Number
- 2248146-2014-00047
- Event Type
- Death
- Date Received
- April 8, 2014
- Date of Event
- February 28, 2014
- Report Date
- March 12, 2014
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- PMA / PMN Number
- K112327
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REPRESENTATIVE SAMPLE WAS TESTED AND FOUND TO PERFORM PER SPECIFICATIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NON-CONFORMANCES WERE FOUND WHICH COULD HAVE CAUSED THE REPORTED EVENT. (B)(4).
Description of Event or Problem · 1
THE PHYSICIAN ATTEMPTED TO INSERT A SENSATION PLUS IAB SHEATHLESS AND WAS UNABLE TO. A MEGA IAB WAS USED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. IT WAS REPORTED THAT THE PATIENT EXPIRED, HOWEVER, IT WAS NOT RELATED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210346 | SENSATION PLUS 50CC IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0684-00-0575 | 3035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Death |