FDA Adverse Event
Injury
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 189874
·
Received September 28, 1998
Report
- Report Number
- 2248146-1998-00857
- Event Type
- Injury
- Date Received
- September 28, 1998
- Date of Event
- July 21, 1998
- Report Date
- July 22, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-00905) AN ALARM SOUNDED FROM THE PUMP AND BLOOD WAS NOTED IN THE TUBING. THE DOCTOR WAS CALLED AND THE PATIENT WAS TAKEN TO THE O.R. AND THE IAB WAS REMOVED. THERE WAS NO DETRIMENT TO THE PATIENT. (DATASCOPE ALSO RECEIVED THE MANDATORY MEDWATCH FROM THE DISTRIBUTOR; UF/DIST REPORT NUMBER: 2026191-1998-0020) ON 10/21/98, DATASCOPE WAS NOTIFIED THAT THE IAB WAS PROBABLY DISCARDED AND WOULD NOT BE RETURNED FOR EVALUATION. [EVENT COMPLICATIONS]: THE IAB WAS SURGICALLY REMOVED - REPORTED 7/23/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 7/23/98.
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 | 72 YR | Required Intervention |