FDA Adverse Event
Malfunction
Summary report: N
SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE
MDR report key: 11595245
·
Received March 31, 2021
Report
- Report Number
- 3008452825-2021-00205
- Event Type
- Malfunction
- Date Received
- March 31, 2021
- Date of Event
- December 22, 2020
- Report Date
- March 31, 2021
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- DRF
- UDI-DI
- 05414734201322
- PMA / PMN Number
- K002976
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ONE 6F, QUADRIPOLAR, JSN, SUPREME EP CATHETER WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED A SEPARATION IN THE CATHETER SHAFT BETWEEN THE GREY AND BLACK AREA ON THE SHAFT OF THE CATHETER AND THE INTERNAL WIRES WERE EXPOSED. FURTHER INVESTIGATION FOUND THAT THE SEPARATION IN THE SHAFT WAS DUE TO INSUFFICIENT BONDING BETWEEN THE GREY AND BLACK PORTIONS OF THE BRAIDED SHAFT.
Description of Event or Problem · 1
THIS REPORT IS TO ADVISE OF AN EVENT NOTED DURING ANALYSIS REVEALING EXPOSED INTERNAL WIRES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 495964 | SUPREME ELECTROPHYSIOLOGY CATHETER, QUADRIPOLAR, 120 CM LENGTH, JSN CURVE, ELE | CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING | DRF | ST. JUDE MEDICAL | 401436 | 7427761 | 05414734201322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |