FDA Adverse Event
Death
Summary report: N
STAT DL 9.5 FR. 34 CC. IAB, INTERNATIONAL
MDR report key: 192293
·
Received October 16, 1998
Report
- Report Number
- 2248146-1998-01176
- Event Type
- Death
- Date Received
- October 16, 1998
- Date of Event
- October 9, 1998
- Report Date
- October 13, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
THE SHEATHLESS INSERTION WAS UNSUCCESSFUL AS THE CATHETER KINKED IN THE FEMORAL ARTERY. THE IAB WAS INSERTED WITH A SHEATH INTO THE PT ON 10/09/1998 AT 8:00 P.M. ON 10/09/1998 AT 12:00 A.M. AFTER IABP FOR ABOUT FOUR HOURS, THE BALLOON RUPTURED WITH A SUDDEN LOSS OF FUNCTION. THE BALLOON WAS REMOVED AND A SECOND IAB WAS INSERTED. THE PT WENT ON TO EXPIRE ON 10/10/1998 AT 4 A.M. IT WAS UNKNOWN IF THE DEATH WAS A RESULT OF THE EVENT BECAUSE THE PT WAS QUITE SICK. EVENT COMPLICATIONS: THE PT WENT ON TO EXPIRE - REPORTED 10/13/1998. PT'S CURRENT STATUS: EXPIRED - REPORTED 10/13/1998.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAT DL 9.5 FR. 34 CC. IAB, INTERNATIONAL | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0684-00-0206-01 | 03/03/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death |