FDA Adverse Event
Malfunction
Summary report: N
INTRO-FLEX PERCUTANEOUS SHEATH INTRODUCER KIT
MDR report key: 1122185
·
Received August 15, 2008
Report
- Report Number
- 6000002-2008-08428
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- April 14, 2008
- Report Date
- April 17, 2008
- Manufacturer
- EDWARDS LIFESCIENCES, PR
- Product Code
- DYB
- PMA / PMN Number
- K885179
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED AND EVALUATED. CUSTOMER REPORT WAS CONFIRMED. THE HEMOSTASIS TYPE INTRODUCER WAS FOUND TO HAVE A TORN DUCKBILL VALVE, AND HALF OF THE VALVE IS MISSING. THE WIPER GASKET IS ALSO TORN, ALLOWING LEAKAGE WITH OR WITHOUT A CATHETER INSERTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER THE CUSTOMER INSERTED INTO THE SHEATH, CUSTOMER PULLED OUT THE DILATOR, THEN THE BLOOD LEAKAGE WAS OBSERVED. NO PATIENT COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRO-FLEX PERCUTANEOUS SHEATH INTRODUCER KIT | INTRODUCER | DYB | EDWARDS LIFESCIENCES, PR | M700F9J | UKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |