FDA Adverse Event
Malfunction
Summary report: N
PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC
MDR report key: 188943
·
Received September 23, 1998
Report
- Report Number
- 2248146-1998-01089
- Event Type
- Malfunction
- Date Received
- September 23, 1998
- Date of Event
- September 18, 1998
- Report Date
- September 18, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-00161) THE 8 FR. IAB LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. ON 10/16/98 IT WAS REPORTED THAT A PATIENT WITH A CORONARY ARTERY DISEASE HAD A BALLOON INSERTED AND BLOOD WAS NOTED IN THE CATHETER. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/18/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 9/18/98.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROFILE 8 FR. 40 CC. IAB WITH ACCESSORIES-DOMESTIC | INTRA-AORTIC BALLOON CATHETER | DSP | DATASCOPE CORP. | 0884-00-0009 | 08/15/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |