FDA Adverse Event
Summary report: N
ICY
MDR report key: 2161225
·
Received July 6, 2011
Report
- Report Number
- 2161225
- Date Received
- July 6, 2011
- Date of Event
- July 4, 2011
- Report Date
- July 6, 2011
- Manufacturer
- ZOLL MEDICAL CORPORATION
- Product Code
- NCX
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
PT HAD INTRAVASCULAR COOLING CATHETER IN RIGHT GROIN. DVT (DEEP VEIN THROMBOSIS) STUDY WAS PERFORMED AND WAS UNABLE TO VISUALIZE RIGHT GROIN 2ND TO CATHETER. CATHETER D/C (DISCONTINUED) THE NEXT DAY. ANOTHER DVT STUDY WAS PERFORMED A WEEK LATER INVOLVING THE RIGHT COMMON FEMORAL CLOT. DR WRITES DVT D/T (DUE TO) COOLING CATHETER. REPORTING AS AN EVENT WHICH MAY OR MAY NOT BE RELATED TO THIS NEW CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICY | INTRAVASCULAR TEMPERATURE MANAGEMENT CATHETER | NCX | ZOLL MEDICAL CORPORATION | IC-3893 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | NONE KNOWN |