FDA Adverse Event
Malfunction
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 188249
·
Received September 16, 1998
Report
- Report Number
- 2248146-1998-01033
- Event Type
- Malfunction
- Date Received
- September 16, 1998
- Date of Event
- August 27, 1998
- Report Date
- September 1, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-01108) THE IAB LEAKED. THIS WAS THE ONLY INFORMATION AT THE TIME OF THE REPORT. ON 10/2/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: BLOOD WAS SEEN IN THE LINE AND THE IAB WAS REMOVED AND ANOTHER WAS INSERTED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR COMPLICATION AS A RESULT OF THE EVENT. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/1/98 AND 10/2/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 9/1/98.
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. | 0684-00-0321 | 06/18/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |