FDA Adverse Event
Malfunction
Summary report: N
SWARTZ BRAIDED TRANSSEPTAL INTRODUCER, SLO, 8.5 F
MDR report key: 2971491
·
Received February 4, 2013
Report
- Report Number
- 3005188751-2013-00021
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- January 9, 2013
- Report Date
- January 10, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC. (AF-MINNETONKA_
- Product Code
- DYB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS, WHEN OUR INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE SWARTZ BRAIDED TRANSSEPTAL INTRODUCER/DILATOR ASSEMBLY WAS ADVANCED OVER THE GUIDEWIRE AND THE SIDE PORT WAS FLUSHED. THE PHYSICIAN NOTED BLOOD LEAKING FROM THE HEMOSTASIS VALVE TO THE INTRODUCER. THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PT. FURTHER INFO WAS REQUESTED BUT NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47711 | SWARTZ BRAIDED TRANSSEPTAL INTRODUCER, SLO, 8.5 F | TRANSSEPTAL CATHETER INTRODUCER | DYB | ST. JUDE MEDICAL, INC. (AF-MINNETONKA_ | G407376 | 3735929 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |