FDA Adverse Event
Malfunction
Summary report: N
FAST-CATH INTRODUCER, TRANSSEPTAL, 8F, SLO CURVE
MDR report key: 1935881
·
Received December 3, 2010
Report
- Report Number
- 3005188751-2010-00123
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Date of Event
- November 4, 2010
- Report Date
- November 8, 2010
- Manufacturer
- ST. JUDE MEDICAL, AF DIV
- Product Code
- DYB
- PMA / PMN Number
- K061015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WE ARE AWAITING DEVICE RETURN. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A F/U REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED AIR BUBBLES WERE OBSERVED ON THE ARM OF THE STOPCOCK TUBE WHEN THE PHYSICIAN ATTEMPTED TO FLUSH THE DEVICE. THERE WERE NO CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FAST-CATH INTRODUCER, TRANSSEPTAL, 8F, SLO CURVE | FAST-CATH INTRO. 8F, SLO | DYB | ST. JUDE MEDICAL, AF DIV | 406948 | 3142671 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |