FDA Adverse Event
Malfunction
Summary report: N
SWARTZ BRAIDED TRANSSEPTAL GUIDING IINT, 8F, SLO
MDR report key: 2852630
·
Received November 27, 2012
Report
- Report Number
- 3005188751-2012-00317
- Event Type
- Malfunction
- Date Received
- November 27, 2012
- Date of Event
- November 6, 2012
- Report Date
- November 7, 2012
- 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 YET BEEN RECEIVED FOR ANALYSIS. WHEN OUR INVESTIGATION IS COMPLETE, A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED DURING AN ABLATION PROCEDURE PERFORMED WITH A SWARTZ BRAIDED TRANSSEPTAL INTRODUCER, AIR BUBBLES WERE NOTED ENTERING THROUGH THE HEMOSTASIS VALVE WHEN THE SIDE PORT WAS FLUSHED. THE PHYSICIAN INSERTED THE GUIDEWIRE INTO THE PT FOLLOWED BY THE INTRODUCER AND DILATOR ASSEMBLY. THE PHYSICIAN THEN ASPIRATED FROM THE SIDE PORT OF THE SWARTZ INTRODUCER AND NOTED AIR BUBBLES COMING FROM THE HEMOSTASIS VALVE. THE LUMEN OF THE INTRODUCER WAS FLUSHED BUT THE AIR BUBBLES DID NOT CLEAR. THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWARTZ BRAIDED TRANSSEPTAL GUIDING IINT, 8F, SLO | TRANSSEPTAL CATHETER INTRODUCER | DYB | ST. JUDE MEDICAL INC. (AF-MINNETONKA) | G407371 | 3762638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | BRK TRANSSEPTAL NEEDLE (MODEL 407209/LOT UNK) |