FDA Adverse Event
Malfunction
Summary report: N
INQUIRY AFOCUSII, 1120-7-4-SM-AF20DL CATHETER
MDR report key: 2556703
·
Received April 27, 2012
Report
- Report Number
- 2030404-2012-00122
- Event Type
- Malfunction
- Date Received
- April 27, 2012
- Date of Event
- April 3, 2012
- Report Date
- April 5, 2012
- Manufacturer
- ST. JUDE MEDICAL, IRVINE
- Product Code
- DRF
- PMA / PMN Number
- K042775
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
WE ARE IN THE PROCESS OF EVALUATED THIS DEVICE. WHEN OUR INVESTIGATION HAS BEEN COMPLETED A F/U REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED DURING A PULMONARY VEIN ISOLATION PROCEDURE THE SHAFT CASING BECAME SEPARATED ON THE AFOCUS II CATHETER. THE PHYSICIAN NOTICED APPROX AN HR AND A HALF INTO THE PROCEDURE THE CATHETER BECAME DIFFICULT TO HANDLE. THE CATHETER WAS REMOVED W/O DIFFICULTY. WHILE EXAMINING THE CATHETER IT WAS NOTED THE CATHETER WAS KINKED AND THE OUTER SHAFT CASING WAS SEPARATED NEAR THE DISTAL END. A NEW AFOCUS II WAS USED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INQUIRY AFOCUSII, 1120-7-4-SM-AF20DL CATHETER | INTRACARDIAC MAPPING CATHER | DRF | ST. JUDE MEDICAL, IRVINE | 87008 | 3536804 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |