FDA Adverse Event
Death
Summary report: N
ANGIOJET AVX RHEOLYTIC THROMBECTOMY CATHETER
MDR report key: 544666
·
Received September 20, 2004
Report
- Report Number
- 2183460-2004-00008
- Event Type
- Death
- Date Received
- September 20, 2004
- Date of Event
- August 19, 2004
- Report Date
- September 20, 2004
- Manufacturer
- POSSIS MEDICAL, INC.
- Product Code
- MCW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PHYSICIAN NOTED DROP IN PRESSURE. DISCONTINUED AND PRESSURE STABILIZED. STARTED USING ANGIOJET AGAIN AND PRESSURE DROPPED. PT HAD TO BE INTUBATED. PT MOVED TO ICU AND EXPIRED APPROX ONE HOUR LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGIOJET AVX RHEOLYTIC THROMBECTOMY CATHETER | AVX 50 | MCW | POSSIS MEDICAL, INC. | AVX | 53119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death |