FDA Adverse Event
Injury
Summary report: N
ANGIODYNAMICS
MDR report key: 471428
·
Received July 11, 2003
Report
- Report Number
- 471428
- Event Type
- Injury
- Date Received
- July 11, 2003
- Date of Event
- May 29, 2003
- Report Date
- June 17, 2003
- Manufacturer
- ANGIODYNAMICS
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OK, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
OUTPATIENT WAS HAVING A LONGTERM HEMODIALYSIS CATHETER REMOVED BECAUSE THEY HAVE A WORKING FISTULA FOR DIALYSIS ACCESS. THE CATHETER BROKE AND BECAME LODGED IN THE RIGHT PULMONARY ARTERY. PT WAS THEN PREPPED AND DRAPED FOR TRANSCATHETER RETRIEVAL OF FOREIGN BODY AND COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGIODYNAMICS | 14CM SCHONCATH | MSD | ANGIODYNAMICS | * | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention |