FDA Adverse Event
Injury
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 189859
·
Received September 29, 1998
Report
- Report Number
- 2248146-1998-01103
- Event Type
- Injury
- Date Received
- September 29, 1998
- Report Date
- September 18, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-01183) A HEMATOMA OCCURED QUICKLY IN THE GROIN WITH A DROP IN BLOOD PRESSURE. THE PATIENT RETURNED TO THE O.R. IMMEDIATELY FOLLOWING THE IAB INSERTION. THEN, THE "SLOW GAS" ALARM SOUNDED AND BLOOD WAS NOTED IN THE TUBING. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01182) THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. [EVENT COMPLICATIONS]: HEMATOMA/DROP IN BLOOD PRESSURE - REPORTED 9/17/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 9/17/98.
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. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |