FDA Adverse Event
Malfunction
Summary report: N
TRANSSEPTAL NEEDLE, BRK XS, ADULT 18 GA, 71CM
MDR report key: 2802562
·
Received October 19, 2012
Report
- Report Number
- 3005188751-2012-00285
- Event Type
- Malfunction
- Date Received
- October 19, 2012
- Report Date
- September 21, 2012
- Manufacturer
- ST. JUDE MEDICAL, AF DIVISION
- Product Code
- DRC
- PMA / PMN Number
- K072278
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RETURNED TO SJM. INVESTIGATION HAS NOT BEEN COMPLETED. WHEN ANALYSIS RESULTS ARE AVAILABLE OR ADDITIONAL INFO BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
IT WAS REPORTED DURING A LEFT SIDED ABLATION PROCEDURE AIR BUBBLES WERE NOTED INSIDE THE BRK TRANSSEPTAL NEEDLE. NO OTHER ANOMALIES WERE NOTED. ANOTHER NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO CONSEQUENCES TO THE PT. ADDITIONAL INFO WAS REQUESTED BUT WAS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSSEPTAL NEEDLE, BRK XS, ADULT 18 GA, 71CM | TRANSSEPTAL NEEDLE | DRC | ST. JUDE MEDICAL, AF DIVISION | G407208 | 3625305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |