FDA Adverse Event
Malfunction
Summary report: N
SORIN BIOMEDICAL INC
MDR report key: 110526
·
Received August 5, 1997
Report
- Report Number
- 2022323-1997-00003
- Event Type
- Malfunction
- Date Received
- August 5, 1997
- Date of Event
- July 9, 1997
- Report Date
- August 5, 1997
- Manufacturer
- SORIN BIOMEDICAL, INC.
- Product Code
- DXE
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING DECLOTTING OF BRACHIAL ARTERY OF PT WITH A PTFE GRAFT, THE PHYSICIAN FELT RESISTANCE IN THE CATHETER. HE RELEASED THE BALLOON (DEFLATED), PULLED BACK, AND AGAIN FELT RESISTANCE AND ADVANCED THE CATHETER WHICH CAME FREE. NO PROBLEM WITH FLOW. CATHETER NOTED TO BE MISSING THE BALLOON UPON REMOVAL. ALL VESSELS OPEN PER SUBSEQUENT RADIOLOGY EXAM. NO CLINICAL SEQUELAE. GRAFT DOING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SORIN BIOMEDICAL INC | ARTERIAL EMBOLECTOMY CATHETER & SYRINGE | DXE | SORIN BIOMEDICAL, INC. | 4EMB80 | 9580509078 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Other |