FDA Adverse Event
Malfunction
Summary report: N
FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS.
MDR report key: 1012482
·
Received March 12, 2008
Report
- Report Number
- 2182269-2008-00085
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- January 21, 2008
- Report Date
- March 12, 2008
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ST. JUDE MEDICAL IS AWAITING DEVICE RETURN. ONCE THE ANALYSIS HAS BEEN COMPLETED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED AN AIR LEAK WAS NOTED AT THE VALVE DURING THE PROCEDURE. AN 8F NAVISTAR WAS USED DURING THE PROCEDURE. THERE WAS NO REPORTED PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS. | FAST-CATH TRANSSEPTAL | DYB | ST. JUDE MEDICAL | NA | 2037135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |