FDA Adverse Event
Malfunction
Summary report: N
SHEATH/HEMOSTASIS VALVE ASSEMBLY
MDR report key: 176692
·
Received July 10, 1998
Report
- Report Number
- 2248146-1998-00756
- Event Type
- Malfunction
- Date Received
- July 10, 1998
- Report Date
- June 29, 1998
- Manufacturer
- DATASCOPE CORP.
- Product Code
- DSP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
EVENT: (CC# 98-00800) THE SHEATH WAS DEFECTIVE WHEN THE IAB WAS REMOVED FROM THE PATIENT. ON 2/2/99, DATASCOPE WAS NOTIFIED THAT IT IS THE POLICY OF THE FACILITY NOT TO RELEASE THE SHEATH. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 6/29/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 6/19/98.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SHEATH/HEMOSTASIS VALVE ASSEMBLY | SHEATH/HEMOSTASIS VALVE ASSEMBLY | DSP | DATASCOPE CORP. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |