FDA Adverse Event
Malfunction
Summary report: N
SWARTZ BRAIDED TRANS INTRODUCER, 8.5F, SLO, 63CM
MDR report key: 2971110
·
Received February 1, 2013
Report
- Report Number
- 3005188751-2013-00015
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- December 26, 2012
- Report Date
- January 7, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
- Product Code
- DYB
- PMA / PMN Number
- K052644
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS NOT YET 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 AND DILATOR ASSEMBLY WAS INSERTED OVER THE GUIDEWIRE AND THE SIDE PORT WAS FLUSHED. THE PHYSICIAN THEN NOTED AIR BUBBLES ENTERING THE SIDE PORT DURING ASPIRATION. THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45276 | SWARTZ BRAIDED TRANS INTRODUCER, 8.5F, SLO, 63CM | TRANSSSEPTAL CATHETER INTRODUCER | DYB | ST. JUDE MEDICAL, INC. (AF-MINNETONKA) | 407451 | 3809200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |