FDA Adverse Event
Malfunction
Summary report: N
HEMOSTASIS INTRODUCER, SL1, 10F, 63CM
MDR report key: 1011296
·
Received March 11, 2008
Report
- Report Number
- 2182269-2008-00081
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 12, 2008
- Report Date
- March 11, 2008
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- DYB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 THE HUB AT THE END OF THE SHEATH WAS LOOSE AND CONTINUED TO TWIST. DURING THE TRANSSEPTAL PROCEDURE THE CARDIOLOGIST WAS UNSURE OF CORRECT ORIENTATION AND A TRANSESOPHAGEAL PROBE HAD TO BE USED. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEMOSTASIS INTRODUCER, SL1, 10F, 63CM | HEMO INTRODUCER SL1, 10F | DYB | ST. JUDE MEDICAL | NA | 2032855 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |