FDA Adverse Event
Malfunction
Summary report: N
FAST-CATH TRANSSEPTAL INT., 8F, SLO, 63 CM
MDR report key: 1012486
·
Received March 12, 2008
Report
- Report Number
- 2182269-2008-00089
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- February 19, 2008
- Report Date
- March 12, 2008
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ONE 8F FAST-CATH INTRODUCER WAS RECEIVED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS MET MFG REQUIREMENTS PRIOR TO SHIPMENT. FUNCTIONAL TESTING IDENTIFIED A LEAK AT THE HEMOSTASIS VALVE WHICH WAS CAUSED BY A TEAR AT BOTH ENDS OF THE MANUFACTURED SLIT OF THE HEMOSTASIS VALVE. IT IS UNCERTAIN WHAT CAUSED THE SEAL TO TEAR.
Description of Event or Problem · 1
IT WAS REPORTED AN AIR LEAK WAS NOTED AT THE HEMOSTASIS VALVE WHEN INSERTING THE LASSO CATHETER AND CHECKING THE AIR ASPIRATION. THERE WAS NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FAST-CATH TRANSSEPTAL INT., 8F, SLO, 63 CM | FAST-CATH TRANS INT SLO | DYB | ST. JUDE MEDICAL | NA | 2009365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |