FDA Adverse Event
Death
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 230126
·
Received July 2, 1999
Report
- Report Number
- 2248146-1999-00025
- Event Type
- Death
- Date Received
- July 2, 1999
- Date of Event
- April 27, 1999
- Report Date
- June 3, 1999
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
(CC# 99-00902) THE IAB WAS INSERTED INTO THE PT ON 4/21/99. ON 4/27/99, THE CATHETER RUPTURED. BLOOD WAS NOTED IN THE TUBING. THE DOCTOR HAD EXTREME DIFFICULTY REMOVING THE IAB. A GRAFT WAS PLACED ON THE RIGHT FEMORAL ARTERY FOR REPAIR OF THE RIGHT PROFUNDA FEMORAL ARTERY AND REPAIR AND ENDARTERECTOMY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY. THE PT WENT ON TO EXPIRE. THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVAL. [EVENT COMPLICATIONS]: INJURY TO ARTERY/SURGERY/EXPIRED- REPORTED 6/3/99. [PT'S CURRENT STATUS]: EXPIRED-RPT'D 6/3/99.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STAT DL 9.5 FR. 40 CC. IAB | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0684-00-0283 | 01/23/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death| R |