FDA Adverse Event
Malfunction
Summary report: N
STAT DL 9.5 FR. 40 CC. IAB
MDR report key: 188360
·
Received September 16, 1998
Report
- Report Number
- 2248146-1998-01008
- Event Type
- Malfunction
- Date Received
- September 16, 1998
- Date of Event
- August 26, 1998
- Report Date
- August 31, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-01071) THE IAB LEAKED UPON INSERTION AND THE IAB WAS REMOVED. (MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBER 98-01070) ON 10/26/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: DURING THE INSERTION OF THE IAB INTO THE PATIENT, THE IAB LEAKED ON INSERTION. A HOLE WAS NOTED IN THE CATHETER. THE IAB WAS REMOVED AND ANOTHER WAS INSERTED. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 8/31/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 8/31/98.
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. | 0684-00-0283 | 05/21/00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |