FDA Adverse Event
Injury
Summary report: N
ANGIODYNAMICS INC.
MDR report key: 340343
·
Received June 29, 2001
Report
- Report Number
- MW1022312
- Event Type
- Injury
- Date Received
- June 29, 2001
- Date of Event
- June 13, 2001
- Report Date
- June 29, 2001
- Manufacturer
- ANGIODYNAMICS, INC
- Product Code
- LIT
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
PT RETAINED FOREIGN BODY IN LEFT FOREARM FOLLOWING RETRIEVAL OF ANGIOPLASTY CATHETER. THE PT WAS TRANSPORTED TO SURGERY. THE CATHETER WAS IDENTIFIED AND RETRIEVED WITH NO FURTHER COMPLICATION. THE PT TOLERATED THE PROCEDURE WELL. PT WAS TRANSPORTED TO THE RECOVERY UNIT AND WAS LATER RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29493 | ANGIODYNAMICS INC. | WORK HORSE PRECUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON | LIT | ANGIODYNAMICS, INC | BALLOON LENGTH 4 CM | 570528 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |